Drug Exclusivity Dashboard
387
products from
224
companies
are estimated to lose exclusivity in the next 5 years
| Company | Trade Name | Approval Date | Estimated End of Exclusivity | Exclusivity Reason |
|---|---|---|---|---|
| Hikma | Hydromorphone Hydrochloride (RX) | Feb 09, 2024 | Dec 02, 2024 | PCPATENT CHALLENGE |
| Somerset | Atropine Sulfate (RX) | Apr 29, 2024 | Dec 04, 2024 | CGTCOMPETITIVE GENERIC THERAPY |
| Sandoz | Hycamtin (RX) 2 products | Oct 11, 2007 | Dec 10, 2024 | 1 patentLatest expiring US Patent No. 8,158,645Compound, corresponding compositions, preparation and/or treatment methods |
| Theravia | Siklos (RX) 2 products | Dec 21, 2017 | Dec 21, 2024 | ODE-177TO REDUCE THE FREQUENCY OF PAINFUL CRISES AND TO REDUCE THE NEED FOR BLOOD TRANSFUSIONS IN PEDIATRIC PATIENTS, 2 YEARS OF AGE AND OLDER, WITH SICKLE CELL ANEMIA WITH RECURRENT MODERATE TO SEVERE PAINFUL CRISIS |
| Somerset | Cupric Chloride (RX) | Apr 30, 2024 | Dec 21, 2024 | CGTCOMPETITIVE GENERIC THERAPY |
| Abbvie | Trilipix (RX) 2 products | Dec 15, 2008 | Jan 07, 2025 | 1 patentLatest expiring US Patent No. 7,259,186Salts of fenofibric acid and pharmaceutical formulations thereof |
| Cephalon | Trisenox (RX) | Oct 13, 2017 | Jan 12, 2025 | ODE-167ARSENIC TRIOXIDE FOR USE IN COMBINATION WITH TRETINOIN FOR TREATMENT OF ADULTS WITH NEWLY-DIAGNOSED LOW-RISK ACUTE PROMYELOCYTIC LEUKEMIA (APL) WHOSE APL IS CHARACTERIZED BY THE PRESENCE OF THE T(15;17) TRANSLOCATION OR PML/RAR-ALPHA GENE EXPRESSION |
| Bausch And Lomb Inc. | Bepreve (RX) | Sep 08, 2009 | Jan 13, 2025 | 1 patentLatest expiring US Patent No. 8,784,789Aqueous liquid preparations and light-stabilized aqueous liquid preparations |
| Cumberland | Sancuso (RX) | Sep 12, 2008 | Jan 22, 2025 | 1 patentLatest expiring US Patent No. 7,608,282Transdermal granisetron |
| Viatris | Geodon (RX) 4 products | Feb 05, 2001 | Jan 28, 2025 | M-232INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES |
| R-Pharm US LLC | Ixempra Kit (RX) 2 products | Oct 16, 2007 | Feb 21, 2025 | 1 patentLatest expiring US Patent No. 7,312,237Combination of epothilone analogs and chemotherapeutic agents for the treatment of prolilferative diseases |
| Galderma Labs LP | Differin (RX) | Jun 19, 2007 | Feb 23, 2025 | 2 patentsLatest expiring US Patent No. 7,579,377Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders |
| Indoco | Lofexidine Hydrochloride (RX) | Aug 20, 2024 | Feb 24, 2025 | CGTCOMPETITIVE GENERIC THERAPY |
| Apotex | Dasatinib (RX) 6 products | Jun 10, 2016 | Mar 02, 2025 | PCPATENT CHALLENGE |
| Amring Pharms | Lysteda (RX) | Nov 13, 2009 | Mar 04, 2025 | 8 patentsLatest expiring US Patent No. 7,947,739Tranexamic acid formulations |
| Padagis Israel | Tazarotene (RX) | Jul 15, 2024 | Mar 08, 2025 | CGTCOMPETITIVE GENERIC THERAPY |
| Fresenius Kabi USA | Smoflipid 20% (RX) 4 products | Jul 13, 2016 | Mar 22, 2025 | NPPNEW PATIENT POPULATION |
| Nobelpharma | Hyftor (RX) | Mar 22, 2022 | Mar 22, 2025 | NPNEW PRODUCT |
| Santarus Inc. | Glumetza (RX) | Jun 03, 2005 | Mar 23, 2025 | 1 patentLatest expiring US Patent No. 7,780,987Controlled release dosage forms |
| Somerset Theraps LLC | Nalbuphine Hydrochloride (RX) 2 products | Sep 19, 2024 | Mar 24, 2025 | CGTCOMPETITIVE GENERIC THERAPY |
| Cipla | Hydrocortisone Sodium Succinate (RX) | Sep 05, 2024 | Mar 25, 2025 | CGTCOMPETITIVE GENERIC THERAPY |
| Strides Pharma | Theophylline (RX) | Sep 05, 2024 | Mar 26, 2025 | CGTCOMPETITIVE GENERIC THERAPY |
| Somerset Theraps LLC | Nalbuphine Hydrochloride (RX) 2 products | Sep 19, 2024 | Mar 30, 2025 | CGTCOMPETITIVE GENERIC THERAPY |
| Somerset | Dexmedetomidine Hydrochloride (RX) 2 products | Sep 24, 2024 | Mar 30, 2025 | CGTCOMPETITIVE GENERIC THERAPY |
| Lupin Ltd. | Prednisolone Acetate (RX) | Aug 02, 2024 | Apr 09, 2025 | CGTCOMPETITIVE GENERIC THERAPY |
| Aurobindo Pharma Ltd. | Cephalexin (RX) 2 products | Sep 27, 2024 | Apr 09, 2025 | CGTCOMPETITIVE GENERIC THERAPY |
| Novartis Pharm | Afinitor Disperz (RX) 3 products | Aug 29, 2012 | Apr 10, 2025 | ODE-169FOR THE ADJUNCTIVE TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WITH TUBEROUS SCLEROSIS COMPLEX (TSC)-ASSOCIATED PARTIAL-ONSET SEIZURES |
| Hikma | Hydromorphone Hydrochloride (RX) | Feb 09, 2024 | Apr 12, 2025 | PCPATENT CHALLENGE |
| Somerset | Zinc Chloride (RX) | Oct 16, 2024 | Apr 14, 2025 | CGTCOMPETITIVE GENERIC THERAPY |
| Torrent | Erythromycin (RX) | Aug 13, 2024 | Apr 22, 2025 | CGTCOMPETITIVE GENERIC THERAPY |
| Merck And Co. Inc. | Emend (RX) | Nov 12, 2010 | May 02, 2025 | D-186ADDITION OF A 3-DAY FOSAPREPITANT FOR INJECTION INTRAVENOUS DOSING REGIMEN IN PEDIATRIC PATIENTS FOR THE CURRENTLY APPROVED PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING |
| Appco | Clomiphene Citrate (RX) | Nov 08, 2024 | May 18, 2025 | CGTCOMPETITIVE GENERIC THERAPY |
| GE Healthcare | Cerianna (RX) | May 20, 2020 | May 20, 2025 | NCENEW CHEMICAL ENTITY |
| Cipla | Nicardipine Hydrochloride In 0.9% Sodium Chloride (RX) 2 products | Sep 24, 2024 | May 21, 2025 | CGTCOMPETITIVE GENERIC THERAPY |
| Astellas | Prograf (RX) 4 products | Apr 08, 1994 | May 24, 2025 | ODE-294PROPHYLAXIS OF ORGAN REJECTION IN PEDIATRIC PATIENTS RECEIVING ALLOGENEIC KIDNEY OR HEART TRANSPLANTS, IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS |
| Astellas | Astagraf Xl (RX) 3 products | Jul 19, 2013 | May 24, 2025 | ODE*FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| Acrotech Biopharma | Folotyn (RX) 2 products | Sep 24, 2009 | May 31, 2025 | 2 patentsLatest expiring US Patent No. 7,622,470Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin |
| Fresenius Kabi USA | Diprivan (RX) | Jun 11, 1996 | Jun 01, 2025 | 1 patentLatest expiring US Patent No. 8,476,010Propofol formulations with non-reactive container closures |
| Sandoz | Ciprodex (RX) | Jul 18, 2003 | Jun 04, 2025 | 1 patentLatest expiring US Patent No. 8,846,650Method of treating middle ear infections |
| Mdgh | Moxidectin (RX) | Jun 13, 2018 | Jun 13, 2025 | ODE-193INDICATED FOR THE TREATMENT OF ONCHOCERCIASIS DUE TO ONCHOCERCA VOLVULUS IN PATIENTS AGED 12 YEARS AND OLDER |
| Janssen Pharms | Xarelto (RX) | Dec 20, 2021 | Jun 20, 2025 | 1 patentLatest expiring US Patent No. 7,157,456Substituted oxazolidinones and their use in the field of blood coagulation PEDPEDIATRIC EXCLUSIVITY |
| Bpi Labs | Ablysinol (RX) | Jun 21, 2018 | Jun 21, 2025 | ODE-192INDICATED TO INDUCE CONTROLLED CARDIAC SEPTAL INFRACTION TO IMPROVE EXERCISE CAPACITY IN ADULTS WITH SYMPTOMATIC HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY WHO ARE NOT CANDIDATES FOR SURGICAL MYECTOMY |
| Eagle Pharms | Ryanodex (RX) | Jul 22, 2014 | Jun 30, 2025 | 1 patentLatest expiring US Patent No. 7,758,890Treatment using dantrolene |
| Biocodex SA | Diacomit (RX) 4 products | Aug 20, 2018 | Jul 14, 2025 | M-281REVISIONS TO THE LABELING TO PROVIDE FOR THE EXPANSION OF THE USE OF STIRIPENTOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME IN PATIENTS TAKING CLOBAZAM TO INCLUDE PEDIATRIC PATIENTS WHO ARE 6 MONTHS TO LESS THAN 2 YEARS OF AGE AND WEIGHING 7 KG OR MORE |
| Glaxosmithkline | Krintafel (RX) | Jul 20, 2018 | Jul 20, 2025 | ODE-201INDICATED FOR THE RADICAL CURE (PREVENTION OF RELAPSE) OF PLASMODIUM VIVAX MALARIA IN PATIENTS AGED 16 YEARS AND OLDER WHO ARE RECEIVING APPROPRIATE ANTIMALARIAL THERAPY FOR ACUTE P. VIVAX INFECTION |
| Fresenius Kabi USA | Omegaven (RX) 2 products | Jul 27, 2018 | Jul 27, 2025 | 3 patentsLatest expiring US Patent No. 9,566,260Treatment and prevention of liver disease associated with parenteral nutrition (PN) ODE-202INDICATED AS A SOURCE OF CALORIES AND FATTY ACIDS IN PEDIATRIC PATIENTS WITH PARENTERAL NUTRITION-ASSOCIATED CHOLESTASIS (PNAC) |
| Dexcel Pharma | Omeprazole (OTC) | Dec 04, 2007 | Aug 16, 2025 | 1 patentLatest expiring US Patent No. 9,023,391Stable benzimidazole formulation |
| Sandoz | Qoliana (RX) | May 22, 2006 | Aug 19, 2025 | 1 patentLatest expiring US Patent No. 7,265,117Topical brimonidine tartrate formulations that lack chlorine dioxide |
| Mylan Speciality LP | Epipen (RX) | Dec 22, 1987 | Sep 11, 2025 | 5 patentsLatest expiring US Patent No. 7,449,012Automatic injector |
| Mylan Speciality LP | Epipen Jr. (RX) | Dec 22, 1987 | Sep 11, 2025 | 5 patentsLatest expiring US Patent No. 7,449,012Automatic injector |
| Mmt | Seizalam (RX) | Sep 14, 2018 | Sep 14, 2025 | ODE-207TREATMENT OF STATUS EPILEPTICUS IN ADULTS |
| Noven Pharms Inc. | Daytrana (RX) 4 products | Apr 06, 2006 | Oct 07, 2025 | 3 patentsLatest expiring US Patent No. 8,632,802Device for transdermal administration of drugs including acrylic polymers |
| Metuchen Pharms | Stendra (RX) 3 products | Apr 27, 2012 | Oct 18, 2025 | 1 patentLatest expiring US Patent No. 6,656,935Aromatic nitrogen-containing 6-membered cyclic compounds M-282REVISIONS TO THE LABELING TO ADD THE RESULTS OF A CLINICAL STUDY (TA-303) IN PATIENTS WITH ED FOLLOWING BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY |
| Janssen Prods | Edurant (RX) | May 20, 2011 | Oct 21, 2025 | 1 patentLatest expiring US Patent No. 7,125,879HIV inhibiting pyrimidines derivatives |
| Sanofi | Renvela (RX) | Oct 19, 2007 | Oct 27, 2025 | 1 patentLatest expiring US Patent No. 7,985,418Aliphatic amine polymer salts for tableting |
| Sentynl Theraps Inc. | Nulibry (RX) | Feb 26, 2021 | Oct 27, 2025 | 1 patentLatest expiring US Patent No. 7,504,095Method for obtaining precursor Z and use thereof for the production of a means for therapy of human molybdenum cofactor deficiency M-286INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION TO INCLUDE RESULTS FROM STUDY ORGN001-102 |
| Sentynl Theraps Inc. | Zokinvy (RX) 2 products | Nov 20, 2020 | Nov 20, 2025 | 2 patentsLatest expiring US Patent No. 8,828,356Farnesyltransferase inhibitors for treatment of laminopathies, cellular aging and atherosclerosis NCENEW CHEMICAL ENTITY |
| Univ Ca Los Angeles | Gallium Ga 68 Gozetotide (RX) | Dec 01, 2020 | Dec 01, 2025 | NCENEW CHEMICAL ENTITY |
| Univ Of Ca San Fran | Gallium Ga 68 Gozetotide (RX) | Dec 01, 2020 | Dec 01, 2025 | NCENEW CHEMICAL ENTITY |
| Pf Prism Cv | Xeljanz (RX) 2 products | Nov 06, 2012 | Dec 08, 2025 | 1 patentPatent reissue RE41783Pyrrolo[2,3-D]pyrimidine compounds I-879TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS, TO THE PRESCRIBING INFORMATION |
| Pfizer | Xeljanz (RX) | Sep 25, 2020 | Dec 08, 2025 | 1 patentPatent reissue RE41783Pyrrolo[2,3-D]pyrimidine compounds |
| Hospira | Precedex (RX) 2 products | Dec 17, 1999 | Dec 16, 2025 | NPPNEW PATIENT POPULATION |
| Novartis | Promacta Kit (RX) 2 products | Aug 24, 2015 | Jan 13, 2026 | 1 patentLatest expiring US Patent No. 7,547,7193′-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hy-drazino]-2′-hydroxy-[1,1′-piphenyl]-acid bis-(monoethanolamine) ODE*FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 3M Health Care | Soluprep S (OTC) | Aug 08, 2018 | Jan 20, 2026 | M-292REVISIONS TO THE LABELING TO DESCRIBE MODIFIED FORMULATION BASED ON RESULTS OF STUDIES EM-05-014624 AND EM-05-014815 |
| Armstrong Pharms | Primatene Mist (OTC) | Nov 07, 2018 | Jan 26, 2026 | 1 patentLatest expiring US Patent No. 8,367,734Stable epinephrine suspension formulation with high inhalation delivery efficiency |
| Viatris | Revatio (RX) 2 products | Nov 18, 2009 | Jan 31, 2026 | M-287LABELING REGARDING NEW DOSING REGIMEN IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) AND TREATMENT OF PAH IN PEDIATRIC PATIENTS (AGES 1-17) |
| UCB Inc. | Briviact (RX) 2 products | May 12, 2016 | Feb 21, 2026 | 1 patentLatest expiring US Patent No. 6,911,4612-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses NPPNEW PATIENT POPULATION |
| Bionpharma | Naproxen Sodium (OTC) | Feb 17, 2006 | Mar 03, 2026 | 5 patentsLatest expiring US Patent No. 10,022,344Liquid dosage forms of sodium naproxen |
| Amphastar Pharms Inc. | Rextovy (RX) | Mar 07, 2023 | Mar 07, 2026 | NPNEW PRODUCT |
| Boehringer Ingelheim | Pradaxa (RX) 6 products | Jun 21, 2021 | Mar 07, 2026 | 1 patentLatest expiring US Patent No. 7,932,2733-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino]propionic acid ethylester methansulfonate and its use as a medicament PEDPEDIATRIC EXCLUSIVITY |
| Waylis Therap | Coreg Cr (RX) 4 products | Oct 20, 2006 | Mar 11, 2026 | 1 patentLatest expiring US Patent No. 8,101,209Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles |
| Currax | Treximet (RX) | Apr 15, 2008 | Apr 02, 2026 | 1 patentLatest expiring US Patent No. 7,332,183Multilayer dosage forms containing NSAIDs and triptans |
| Viiv Healthcare | Vocabria (RX) | Jan 21, 2021 | Apr 28, 2026 | 2 patentsLatest expiring US Patent No. 10,927,129N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3] oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide having HIV integrase inhibitory activity M-273REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY 207966 ATLAS-2M |
| Organon | Zetia (RX) | Oct 25, 2002 | Apr 30, 2026 | 1 patentLatest expiring US Patent No. 7,612,058Methods for inhibiting sterol absorption |
| Foldrx Pharms | Vyndaqel (RX) | May 03, 2019 | May 03, 2026 | 2 patentsLatest expiring US Patent No. 7,214,695Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding ODE-237TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY AND CARDIOVASCULAR-RELATED HOSPITALIZATION |
| Abbvie | Lexapro (RX) 3 products | Aug 14, 2002 | May 12, 2026 | NPPNEW PATIENT POPULATION |
| Biomarin Pharm | Kuvan (RX) | Dec 13, 2007 | May 16, 2026 | 9 patentsLatest expiring US Patent No. 7,566,462Stable tablet formulation |
| Takeda Pharms USA | Gattex Kit (RX) | Dec 21, 2012 | May 16, 2026 | 2 patentsLatest expiring US Patent No. 7,847,061Treatment of short bowel syndrome patients with colon-in-continuity ODE-240TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT |
| PTC Therap | Emflaza (RX) 5 products | Feb 09, 2017 | Jun 07, 2026 | ODE-252TREATMENT OF DUCHENE MUSCULAR DYSTROPHY IN PATIENTS 2 YEARS OF AGE TO LESS THAN 5 YEARS OF AGE |
| Braintree Labs | Suflave (RX) | Jun 15, 2023 | Jun 15, 2026 | NPNEW PRODUCT |
| Endo Operations | Supprelin La (RX) | May 03, 2007 | Jun 16, 2026 | 1 patentLatest expiring US Patent No. 8,062,652Compositions and methods for treating precocious puberty |
| Assertio | Cambia (RX) | Jun 17, 2009 | Jun 16, 2026 | 4 patentsLatest expiring US Patent No. 7,759,394Diclofenac formulations and methods of use |
| Bausch | Aplenzin (RX) 3 products | Apr 23, 2008 | Jun 27, 2026 | 8 patentsLatest expiring US Patent No. 7,241,805Modified release formulations of a bupropion salt |
| Mission Pharma | Thiola (RX) | Aug 11, 1988 | Jun 28, 2026 | ODE-267INDICATED IN COMBINATION WITH HIGH FLUID INTAKE, ALKALI, AND DIET MODIFICATION, FOR THE PREVENTION OF CYSTINE STONE FORMATION IN PEDIATRIC PATIENTS 20KG TO 9 YEARS OF AGE W/SEVERE HOMOZYGOUS CYSTINURIA, WHO ARE NOT RESPONSIVE TO THESE MEASURES ALONE |
| Catalyst Pharms | Fycompa (RX) 7 products | Oct 22, 2012 | Jul 01, 2026 | 2 patentsLatest expiring US Patent No. 8,772,497Method for producing 1, 2-dihydropyridine-2-one compound |
| Laboratoire Hra | Opill (OTC) | N/A | Jul 13, 2026 | RTORX TO OTC SWITCH OR OTC USE |
| Thea Pharma | Akten (RX) | Oct 07, 2008 | Jul 24, 2026 | 1 patentLatest expiring US Patent No. 8,759,401Aqueous gel formulation and method for inducing topical anesthesia |
| Msd Sub Merck | Bridion (RX) 2 products | Dec 15, 2015 | Jul 27, 2026 | 1 patentPatent reissue RE447336-mercapto-cyclodextrin derivatives:reversal agents for drug-induced neuromuscular block M-291REVISIONS TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE PACKAGE INSERT TO INCLUDE THE RESULT OF STUDY P145 |
| Avanir Pharms | Nuedexta (RX) | Oct 29, 2010 | Aug 13, 2026 | 1 patentLatest expiring US Patent No. 7,659,282Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders |
| Noden Pharma | Tekturna (RX) 2 products | Mar 05, 2007 | Aug 19, 2026 | 1 patentLatest expiring US Patent No. 8,617,595Galenic formulations of organic compounds |
| Uihc Pet Imaging | Gallium Ga 68 Edotreotide (RX) | Aug 21, 2019 | Aug 21, 2026 | WEXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY |
| Mylan Speciality LP | Dymista (RX) | May 01, 2012 | Aug 24, 2026 | 2 patentsLatest expiring US Patent No. 8,168,620Combination of azelastine and steroids |
| Glaxo Grp Ltd. | Flovent Hfa (RX) 2 products | May 14, 2004 | Aug 26, 2026 | 1 patentLatest expiring US Patent No. 7,500,444Actuation indicator for a dispensing device |
| Amgen | Sensipar (RX) 3 products | Mar 08, 2004 | Sep 22, 2026 | 2 patentsLatest expiring US Patent No. 7,829,595Rapid dissolution formulation of a calcium receptor-active compound |
| Bristol Myers Squibb | Sprycel (RX) 6 products | Jun 28, 2006 | Sep 28, 2026 | 2 patentsLatest expiring US Patent No. 7,491,725Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors PEDPEDIATRIC EXCLUSIVITY |
| Cyclomedica | Technegas Kit (RX) | Sep 29, 2023 | Sep 29, 2026 | NPNEW PRODUCT |
| Ani Pharms | Veregen (RX) | Oct 31, 2006 | Oct 02, 2026 | 2 patentsLatest expiring US Patent No. 7,858,662Medicament for the treatment of viral skin and tumour diseases |
| Eisai Inc. | Aricept (RX) | Jul 23, 2010 | Oct 04, 2026 | 1 patentLatest expiring US Patent No. 8,481,565Method for stabilizing anti-dementia drug |
| Allergan | Saphris (RX) 3 products | Aug 13, 2009 | Oct 06, 2026 | 2 patentsLatest expiring US Patent No. 7,741,358Crystal form of asenapine maleate |
| Besins Healthcare | Androgel (RX) 3 products | Apr 29, 2011 | Oct 12, 2026 | 8 patentsLatest expiring US Patent No. 8,466,136Testosterone gel and method of use |
| Alexza Pharms | Adasuve (RX) | Dec 21, 2012 | Oct 23, 2026 | 5 patentsLatest expiring US Patent No. 8,387,612Self-contained heating unit and drug-supply unit employing same |
| Fresenius Kabi USA | Naropin (RX) 2 products | Sep 24, 1996 | Nov 28, 2026 | 3 patentsLatest expiring US Patent No. 7,857,802Connector for medical liquid-containing packages and medical liquid-containing packages |
| Padagis US | Clindesse (RX) | Nov 30, 2004 | Dec 02, 2026 | 1 patentLatest expiring US Patent No. 9,789,057Pharmaceutical delivery system |
| Wyeth Pharms | Protonix (RX) | Nov 14, 2007 | Dec 07, 2026 | 4 patentsLatest expiring US Patent No. 7,544,370Pantoprazole multiparticulate formulations |
| Amgen Inc. | Corlanor (RX) | Apr 22, 2019 | Dec 12, 2026 | 4 patentsLatest expiring US Patent No. 7,867,996γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it PEDPEDIATRIC EXCLUSIVITY |
| Recordati Rare | Signifor (RX) 3 products | Dec 14, 2012 | Dec 14, 2026 | 2 patentsLatest expiring US Patent No. 7,473,761Somatostatin analogues |
| Dutch Ophthalmic | Tissueblue (RX) | Dec 20, 2019 | Dec 20, 2026 | ODE-282INDICATED TO SELECTIVELY STAIN THE INTERNAL LIMITING MEMBRANE (ILM) |
| Cumberland | Vibativ (RX) | Sep 11, 2009 | Jan 01, 2027 | 1 patentLatest expiring US Patent No. 7,531,623Hydrochloride salts of a glycopeptide phosphonate derivative |
| Collegium Pharm Inc. | Nucynta (RX) 3 products | Nov 20, 2008 | Jan 03, 2027 | 1 patentLatest expiring US Patent No. 7,994,364Crystalline forms of (−)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride PEDPEDIATRIC EXCLUSIVITY |
| Am Regent | Injectafer (RX) | Jul 25, 2013 | Jan 08, 2027 | 4 patentsLatest expiring US Patent No. 11,364,260Methods and compositions for administration of iron NPPNEW PATIENT POPULATION |
| Provepharm Sas | Provayblue (RX) 2 products | Apr 08, 2016 | Jan 08, 2027 | M-303INFORMATION ADDED TO THE CLINICAL STUDIES SECTION TO FULFILL A POST-MARKETING REQUIREMENT |
| Harrow Eye | Nevanac (RX) | Aug 19, 2005 | Jan 31, 2027 | 3 patentsLatest expiring US Patent No. 7,834,059Topical nepafenac formulations |
| Astellas | Lexiscan (RX) | Apr 10, 2008 | Feb 02, 2027 | 2 patentsLatest expiring US Patent No. 8,106,183Process for preparing an A2A-adenosine receptor agonist and its polymorphs |
| Btg Intl | Aurlumyn (RX) | Feb 13, 2024 | Feb 13, 2027 | NPNEW PRODUCT |
| Valeant Pharms Intl | Colazal (RX) | Jul 18, 2000 | Feb 24, 2027 | 2 patentsLatest expiring US Patent No. 7,452,872Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives |
| Haleon US Holdings | Advil Allergy Sinus (OTC) | Dec 19, 2002 | Feb 28, 2027 | 1 patentLatest expiring US Patent No. 7,863,287Compositions of non-steroidal anti-inflammatory drugs, decongestants and anti-histamines |
| Otsuka | Abilify (RX) 6 products | Nov 15, 2002 | Mar 02, 2027 | 3 patentsLatest expiring US Patent No. 8,759,350Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders |
| Wyeth Pharms | Duavee (RX) | Oct 03, 2013 | Mar 10, 2027 | 2 patentsLatest expiring US Patent No. 7,683,051Crystalline polymorph of bazedoxifene acetate |
| Actelion | Veletri (RX) 2 products | Jun 27, 2008 | Mar 15, 2027 | 2 patentsLatest expiring US Patent No. 8,318,802Epoprostenol formulation and method of making thereof |
| Supernus Pharms | Oxtellar Xr (RX) 3 products | Oct 19, 2012 | Apr 13, 2027 | 11 patentsLatest expiring US Patent No. 10,220,042Modified release preparations containing oxcarbazepine and derivatives thereof |
| Summit Biosci | Rezenopy (RX) | Apr 19, 2024 | Apr 19, 2027 | NPNEW PRODUCT |
| Baxter Healthcare Corp. | Clinolipid 20% (RX) | Oct 03, 2013 | Apr 24, 2027 | NPPNEW PATIENT POPULATION |
| Becton Dickinson Co. | Chloraprep With Tint (OTC) 3 products | May 03, 2005 | Apr 25, 2027 | 2 patentsLatest expiring US Patent No. 7,422,388Applicator for coloring antiseptic |
| Avid Radiopharms Inc. | Amyvid (RX) | Apr 06, 2012 | Apr 30, 2027 | 2 patentsLatest expiring US Patent No. 7,687,052Styrylpyridine derivatives and their use for binding and imaging amyloid plaques |
| Upjohn | Lyrica Cr (RX) 3 products | Oct 11, 2017 | May 02, 2027 | 3 patentsLatest expiring US Patent No. 10,022,447Solid pharmaceutical compositions containing pregabalin |
| Biocryst | Rapivab (RX) | Dec 19, 2014 | May 07, 2027 | 2 patentsLatest expiring US Patent No. 8,778,997Antiviral treatments |
| Endo Operations | Aveed (RX) | Mar 05, 2014 | May 08, 2027 | 2 patentsLatest expiring US Patent No. 8,338,395Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels |
| Merck Sharp Dohme | Januvia (RX) 3 products | Oct 16, 2006 | May 24, 2027 | 1 patentLatest expiring US Patent No. 7,326,708Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor PEDPEDIATRIC EXCLUSIVITY |
| Msd Sub Merck | Janumet Xr (RX) 3 products | Feb 02, 2012 | May 24, 2027 | 1 patentLatest expiring US Patent No. 7,326,708Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor PEDPEDIATRIC EXCLUSIVITY |
| Avion Pharms | Balcoltra (RX) | Jan 09, 2018 | Jun 01, 2027 | 1 patentLatest expiring US Patent No. 7,838,042Hypoallergenic metal amino acid chelates and metal amino acid chelate-containing compositions |
| Amgen Inc. | Corlanor (RX) 2 products | Apr 15, 2015 | Jun 12, 2027 | 4 patentsLatest expiring US Patent No. 7,867,996γ-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it |
| Abbvie | Lumigan (RX) | Aug 31, 2010 | Jun 13, 2027 | 12 patentsLatest expiring US Patent No. 7,851,504Enhanced bimatoprost ophthalmic solution |
| Twi Pharms | Forfivo Xl (RX) | Nov 10, 2011 | Jun 25, 2027 | 1 patentLatest expiring US Patent No. 7,674,479Sustained-release bupropion and bupropion/mecamylamine tablets |
| Janssen Prods | Prezista (RX) 5 products | Feb 25, 2008 | Jun 26, 2027 | 2 patentsLatest expiring US Patent No. 7,700,645Pseudopolymorphic forms of a HIV protease inhibitor |
| Coopersurgical | Paragard T 380A (RX) | Nov 15, 1984 | Jun 28, 2027 | D-193NEW INSERTER INTENDED TO FACILITATE SINGLE-HAND PLACEMENT |
| Pf Prism Cv | Pristiq (RX) 3 products | Feb 29, 2008 | Jul 05, 2027 | 1 patentLatest expiring US Patent No. 8,269,040Derivatives of venlafaxine and methods of preparing and using the same |
| Eisai Inc. | Halaven (RX) | Nov 15, 2010 | Jul 08, 2027 | 2 patentsPatent reissue RE46965Intermediates for the preparation of analogs of Halichondrin B PEDPEDIATRIC EXCLUSIVITY |
| Galderma Labs LP | Epiduo (RX) | Dec 08, 2008 | Jul 18, 2027 | 5 patentsLatest expiring US Patent No. 8,071,644Combinations of adapalene and benzoyl peroxide for treating acne lesions |
| Millicent Pr | Femlyv (RX) | Jul 22, 2024 | Jul 22, 2027 | NPNEW PRODUCT |
| Mylan Speciality LP | Sfrowasa (RX) | Jun 20, 2008 | Jul 24, 2027 | 1 patentLatest expiring US Patent No. 7,645,801Reduced irritant enema for treatment of inflammatory bowel disease (IBD) |
| Akarx Inc. | Doptelet (RX) | May 21, 2018 | Jul 28, 2027 | 1 patentLatest expiring US Patent No. 7,638,5362-Acylaminothiazole derivative or salt thereof ODE-246TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT |
| Braintree Labs | Suprep Bowel Prep Kit (RX) | Aug 05, 2010 | Aug 05, 2027 | ODE-315FOR CLEANSING OF THE COLON AS A PREPARATION FOR COLONOSCOPY IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| Bayer Healthcare | Lampit (RX) 2 products | Aug 06, 2020 | Aug 06, 2027 | ODE-319INDICATED IN PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE AND WEIGHING AT LEAST 2.5 KG) FOR THE TREATMENT OF CHAGAS DISEASE (AMERICAN TRYPANOSOMIASIS) CAUSED BY TRYPANOSOMA CRUZI |
| Wyeth Pharms | Protonix Iv (RX) | Mar 22, 2001 | Aug 12, 2027 | NPPNEW PATIENT POPULATION |
| Alimera Sciences Inc. | Iluvien (RX) | Sep 26, 2014 | Aug 12, 2027 | 1 patentLatest expiring US Patent No. 8,871,241Injectable sustained release delivery devices |
| Astellas | Xtandi (RX) | Aug 31, 2012 | Aug 13, 2027 | 3 patentsLatest expiring US Patent No. 7,709,517Diarylhydantoin compounds I-926TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (NMCSPC) WITH BIOCHEMICAL RECURRENCE AT HIGH RISK FOR METASTASIS |
| Btg Intl | Vistogard (RX) | Dec 11, 2015 | Aug 17, 2027 | 1 patentLatest expiring US Patent No. 7,776,838Treatment of chemotherapeutic agent and antiviral agent toxicity with acylated pyrimidine nucleosides |
| Chiesi | Juxtapid (RX) 4 products | Dec 21, 2012 | Aug 19, 2027 | 8 patentsLatest expiring US Patent No. 7,932,268Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects |
| Purdue Pharma LP | Oxycontin (RX) 3 products | Apr 05, 2010 | Aug 24, 2027 | 17 patentsLatest expiring US Patent No. 11,304,908Tamper resistant dosage forms |
| Teva | Azilect (RX) 2 products | May 16, 2006 | Aug 27, 2027 | 2 patentsLatest expiring US Patent No. 7,815,942Rasagiline formulations of improved content uniformity |
| Astellas | Cresemba (RX) | Mar 06, 2015 | Sep 06, 2027 | 1 patentLatest expiring US Patent No. 6,812,238N-substituted carbamoyloxyalkyl-azolium derivatives GAINGENERATING ANTIBIOTIC INCENTIVES NOW |
| Merck | Emend (RX) 2 products | Mar 26, 2003 | Sep 26, 2027 | 1 patentLatest expiring US Patent No. 8,258,132Pharmaceutical composition of a tachykinin receptor antagonist |
| Msd Merck Co. | Emend (RX) | Dec 17, 2015 | Sep 26, 2027 | 1 patentLatest expiring US Patent No. 8,258,132Pharmaceutical composition of a tachykinin receptor antagonist |
| Sage Prods | Chlorhexidine Gluconate (OTC) | Apr 25, 2005 | Oct 02, 2027 | 4 patentsLatest expiring US Patent No. 7,935,093Disinfectant delivery system and method of providing alcohol-free disinfection |
| Chattem Sanofi | Xyzal Allergy 24Hr (OTC) | Jan 31, 2017 | Oct 16, 2027 | 1 patentLatest expiring US Patent No. 8,633,194Pharmaceutical composition of piperazine derivatives |
| Sucampo Pharma LLC | Amitiza (RX) 2 products | Jan 31, 2006 | Oct 25, 2027 | 4 patentsLatest expiring US Patent No. 8,026,393Soft-gelatin capsule formulation |
| Acrotech Biopharma | Beleodaq (RX) | Jul 03, 2014 | Oct 27, 2027 | 2 patentsLatest expiring US Patent No. 8,835,501Pharmaceutical formulations of HDAC inhibitors |
| Pharmaxis Europe | Bronchitol (RX) | Oct 30, 2020 | Oct 30, 2027 | ODE-327ADD-ON MAINTENANCE THERAPY TO IMPROVE PULMONARY FUNCTION IN ADULT PATIENTS 18 YEARS OF AGE AND OLDER WITH CYSTIC FIBROSIS AND WHO HAVE PASSED THE BRONCHITOL TOLERANCE TEST |
| Cara Therap | Korsuva (RX) | Aug 23, 2021 | Nov 12, 2027 | 12 patentsLatest expiring US Patent No. 10,017,536Synthetic peptide amides and dimers thereof NCENEW CHEMICAL ENTITY |
| Abbvie | Acular Ls (RX) | May 30, 2003 | Nov 24, 2027 | 8 patentsLatest expiring US Patent No. 8,008,338Ketorolac tromethamine compositions for treating or preventing ocular pain |
| Pfizer | Toviaz (RX) 2 products | Oct 31, 2008 | Dec 07, 2027 | 3 patentsLatest expiring US Patent No. 7,807,715Pharmaceutical compositions comprising fesoterodine PEDPEDIATRIC EXCLUSIVITY |
| Cheplapharm | Valcyte (RX) | Aug 28, 2009 | Dec 11, 2027 | 2 patentsLatest expiring US Patent No. 8,889,109Pharmaceutical dosage forms comprising valganciclovir hydrochloride |
| Galderma Labs LP | Oracea (RX) | May 26, 2006 | Dec 19, 2027 | 6 patentsLatest expiring US Patent No. 7,749,532Once daily formulations of tetracyclines |
| Abbvie | Lastacaft (OTC) | Jul 28, 2010 | Dec 23, 2027 | 2 patentsLatest expiring US Patent No. 8,664,215Ocular allergy treatments with alcaftadine |
| Novartis | Gilenya (RX) | Sep 21, 2010 | Dec 25, 2027 | 3 patentsLatest expiring US Patent No. 10,543,179Dosage regimen of an S1P receptor modulator |
| Chiesi | Cardene In 4.8% Dextrose In Plastic Container (RX) | Jul 31, 2008 | Dec 26, 2027 | 6 patentsLatest expiring US Patent No. 7,612,102Pre-mixed, ready-to-use pharmaceutical compositions |
| Chiesi | Cardene In 0.86% Sodium Chloride In Plastic Container (RX) | Jul 31, 2008 | Dec 26, 2027 | 6 patentsLatest expiring US Patent No. 7,612,102Pre-mixed, ready-to-use pharmaceutical compositions |
| Chiesi | Cardene In 0.83% Sodium Chloride In Plastic Container (RX) | Nov 07, 2008 | Dec 26, 2027 | 6 patentsLatest expiring US Patent No. 7,612,102Pre-mixed, ready-to-use pharmaceutical compositions |
| Actelion | Tracleer (RX) | Sep 05, 2017 | Dec 28, 2027 | 2 patentsLatest expiring US Patent No. 7,959,945Dispersible bosentan tablet ODE-161TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) IN PEDIATRIC PATIENTS AGED 3 YRS AND OLDER WITH IDIOPATHIC OR CONGENITAL PAH TO IMPROVE PULMONARY VASCULAR RESISTANCE (PVR), WHICH IS EXPECTED TO RESULT IN AN IMPROVEMENT IN EXERCISE ABILITY |
| Apil | Atelvia (RX) | Oct 08, 2010 | Jan 09, 2028 | 3 patentsLatest expiring US Patent No. 7,645,459Dosage forms of bisphosphonates |
| Alimera Sciences Inc. | Yutiq (RX) | Oct 12, 2018 | Jan 12, 2028 | 2 patentsLatest expiring US Patent No. 7,998,108Injector apparatus and method of use |
| UCB Inc. | Nayzilam (RX) | May 17, 2019 | Jan 18, 2028 | 4 patentsLatest expiring US Patent No. 8,217,033Methods and compositions for the delivery of a therapeutic agent ODE-243ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT'S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER |
| Recordati Rare | Carbaglu (RX) | Mar 18, 2010 | Jan 22, 2028 | ODE-345IN PEDIATRIC AND ADULT PATIENTS AS ADJUNCTIVE THERAPY TO STANDARD OF CARE FOR THE TREATMENT OF ACUTE HYPERAMMONEMIA DUE TO PROPIONIC ACIDEMIA (PA) OR METHYLMALONIC ACIDEMIA (MMA) |
| Kyowa Kirin | Nourianz (RX) 2 products | Aug 27, 2019 | Jan 28, 2028 | 3 patentsLatest expiring US Patent No. 7,727,993Administering adenosine A2A receptor antagonist to reduce or suppress side effects of parkinson's disease therapy NCENEW CHEMICAL ENTITY |
| Bayer Healthcare | Natazia (RX) | May 06, 2010 | Jan 30, 2028 | 2 patentsLatest expiring US Patent No. 8,153,616Combination preparation for oral contraception and oral therapy of dysfunctional uterine bleeding containing estradiol valerate and dienogest and method of using same |
| Cubist Pharms LLC | Dificid (RX) | May 27, 2011 | Jan 31, 2028 | 5 patentsLatest expiring US Patent No. 7,378,508Polymorphic crystalline forms of tiacumicin B ODE-367PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER FOR THE TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA (CDAD) |
| Covis | Alvesco (RX) 2 products | Jan 10, 2008 | Feb 01, 2028 | 1 patentLatest expiring US Patent No. 8,371,292Use of ciclesonide for the treatment of respiratory diseases |
| Covis | Omnaris (RX) | Oct 20, 2006 | Feb 01, 2028 | 1 patentLatest expiring US Patent No. 8,371,292Use of ciclesonide for the treatment of respiratory diseases |
| Novartis | Promacta (RX) 4 products | Nov 20, 2008 | Feb 01, 2028 | 6 patentsLatest expiring US Patent No. 8,052,9933′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine) ODE-210INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA |
| Mayne Pharma | Doryx (RX) 2 products | Apr 11, 2013 | Feb 03, 2028 | 1 patentLatest expiring US Patent No. 8,715,724Tabletting process |
| Indivior | Perseris Kit (RX) 2 products | Jul 27, 2018 | Feb 13, 2028 | 10 patentsLatest expiring US Patent No. 10,010,612Sustained delivery formulations of risperidone compounds |
| Am Regent | Injectafer (RX) 3 products | Oct 08, 2020 | Feb 15, 2028 | 6 patentsLatest expiring US Patent No. 7,754,702Methods and compositions for administration of iron NPPNEW PATIENT POPULATION |
| Bristol Myers Squibb | Revlimid (RX) 6 products | Dec 27, 2005 | Mar 08, 2028 | 3 patentsLatest expiring US Patent No. 8,741,929Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of mantle cell lymphomas ODE-245INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL) |
| Astellas | Cresemba (RX) 2 products | Mar 06, 2015 | Mar 14, 2028 | 3 patentsLatest expiring US Patent No. 10,206,879Active ingredient containing stabilised solid forms and method for the production thereof GAINGENERATING ANTIBIOTIC INCENTIVES NOW |
| Msd Sub Merck | Zolinza (RX) | Oct 06, 2006 | Mar 18, 2028 | 5 patentsLatest expiring US Patent No. 8,450,372Formulations of suberoylanilide hydroxamic acid and methods for producing same |
| Azurity | Edarbi (RX) 2 products | Feb 25, 2011 | Mar 26, 2028 | 3 patentsLatest expiring US Patent No. 9,066,936Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent |
| Daiichi Sankyo Inc. | Savaysa (RX) 3 products | Jan 08, 2015 | Mar 28, 2028 | 2 patentsLatest expiring US Patent No. 9,149,532Pharmaceutical composition M-14ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION |
| Mylan | Vusion (RX) | Feb 16, 2006 | Mar 30, 2028 | 1 patentLatest expiring US Patent No. 8,147,852Modified azole compounds as antifungal and antibacterial agents |
| Supernus Pharms | Trokendi Xr (RX) 4 products | Aug 16, 2013 | Apr 04, 2028 | 10 patentsLatest expiring US Patent No. 8,298,576Sustained-release formulations of topiramate |
| Haleon US Holdings | Nicorette (OTC) 2 products | Feb 09, 1996 | Apr 30, 2028 | 1 patentLatest expiring US Patent No. 8,323,683Flavoring of drug-containing chewing gums |
| Chiesi | Ferriprox (RX) 2 products | Oct 14, 2011 | Apr 30, 2028 | ODE-421TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN ADULT AND PEDIATRIC PATIENTS 8 YEARS OF AGE AND OLDER WITH SICKLE CELL DISEASE OR OTHER ANEMIAS |
| Tasman Pharma | Versacloz (RX) | Feb 06, 2013 | May 01, 2028 | 1 patentLatest expiring US Patent No. 8,057,811Stable clozapine suspension formulation |
| Mayne Pharma | Sorilux (RX) | Oct 06, 2010 | May 07, 2028 | 2 patentsLatest expiring US Patent No. 8,263,580Vitamin formulation |
| Sprout Pharms | Addyi (RX) | Aug 18, 2015 | May 09, 2028 | 1 patentLatest expiring US Patent No. 7,151,103Method of treating female hypoactive sexual desire disorder with flibanserin |
| Almatica | Venlafaxine Besylate (RX) | Jun 29, 2022 | May 16, 2028 | 1 patentLatest expiring US Patent No. 7,776,358Extended release venlafaxine besylate tablets |
| Abbvie | Dalvance (RX) | May 23, 2014 | May 23, 2028 | 1 patentLatest expiring US Patent No. 6,900,175Methods of administering dalbavancin for treatment of bacterial infections GAINGENERATING ANTIBIOTIC INCENTIVES NOW |
| Recordati Rare | Signifor Lar Kit (RX) 5 products | Dec 15, 2014 | May 23, 2028 | 3 patentsLatest expiring US Patent No. 9,351,923Extended-release composition comprising a somatostatin derivative in microparticles ODE-268INDICATED FOR TREATMENT OF PATIENTS WITH CUSHING'S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE |
| Galt Pharms | Doral (RX) | Dec 27, 1985 | Jun 03, 2028 | 1 patentLatest expiring US Patent No. 7,608,616Methods for reducing the risk of an adverse drug interaction in a patient suffering from insomnia |
| Bayer Healthcare | Astepro Allergy (OTC) | Jun 17, 2021 | Jun 04, 2028 | 3 patentsLatest expiring US Patent No. 8,071,073Compositions comprising azelastine and methods of use thereof |
| Bayer Healthcare | Children'S Astepro Allergy (OTC) | Jun 17, 2021 | Jun 04, 2028 | 3 patentsLatest expiring US Patent No. 8,071,073Compositions comprising azelastine and methods of use thereof |
| Abbvie | Canasa (RX) | Nov 05, 2004 | Jun 06, 2028 | 2 patentsLatest expiring US Patent No. 8,217,083Mesalamine suppository |
| Takeda Pharms USA | Duetact (RX) 2 products | Jul 28, 2006 | Jun 08, 2028 | 2 patentsLatest expiring US Patent No. 8,071,130Solid preparation |
| Glaxosmithkline LLC | Lamictal Xr (RX) 6 products | May 29, 2009 | Jun 14, 2028 | 1 patentLatest expiring US Patent No. 8,637,512Formulations and method of treatment |
| Sarepta Theraps Inc. | Vyondys 53 (RX) | Dec 12, 2019 | Jun 28, 2028 | 8 patentsPatent reissue RE47691Antisense oligonucleotides for inducing exon skipping and methods of use thereof NCENEW CHEMICAL ENTITY |
| Novartis | Afinitor (RX) 4 products | Mar 30, 2009 | Jul 01, 2028 | 2 patentsLatest expiring US Patent No. 9,006,224Neuroendocrine tumor treatment |
| Janssen Prods | Yondelis (RX) | Oct 23, 2015 | Jul 07, 2028 | 1 patentLatest expiring US Patent No. 8,895,557Pharmaceutical formulations of ecteinascidin compounds |
| Duchesnay | Osphena (RX) | Feb 26, 2013 | Jul 09, 2028 | 7 patentsLatest expiring US Patent No. 8,642,079Solid formulations of ospemifene |
| Astellas | Prograf (RX) 2 products | May 24, 2018 | Jul 16, 2028 | ODE-360FOR PROPHYLAXIS OF ORGAN REJECTION IN ADULT AND PEDIATRIC PATIENTS RECEIVING ALLOGENEIC LUNG TRANSPLANT |
| Sanofi | Fexinidazole (RX) | Jul 16, 2021 | Jul 16, 2028 | ODE-359FOR THE TREATMENT OF BOTH THE FIRST-STAGE (HEMOLYMPHATIC) AND SECOND-STAGE (MENINGOENCEPHALITIC) HUMAN AFRICAN TRYPANOSOMIASIS (HAT) DUE TO TRYPANOSOMA BRUCEI GAMBIENSE IN PATIENTS 6 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 20 KG |
| Harrow Eye | Tobradex St (RX) | Feb 13, 2009 | Aug 03, 2028 | 3 patentsLatest expiring US Patent No. 7,795,316Topical ophthalmic compositions containing tobramycin and dexamethasone |
| Sandoz | Reclast (RX) | Apr 16, 2007 | Aug 05, 2028 | 1 patentLatest expiring US Patent No. 7,932,241Pharmaceutical products comprising bisphosphonates |
| Genzyme Corp. | Caprelsa (RX) 2 products | Apr 06, 2011 | Aug 08, 2028 | 1 patentLatest expiring US Patent No. 8,067,427Pharmaceutical compositions comprising ZD6474 |
| Protega Pharms | Roxybond (RX) 4 products | Apr 20, 2017 | Aug 12, 2028 | 2 patentsLatest expiring US Patent No. 10,314,788Pharmaceutical compositions configured to deter dosage form splitting |
| Agile | Twirla (RX) | Feb 14, 2020 | Aug 26, 2028 | 3 patentsLatest expiring US Patent No. 8,246,978Dermal delivery device with reduced loss of its volatile components |
| Pfizer | Vizimpro (RX) 3 products | Sep 27, 2018 | Aug 26, 2028 | 4 patentsLatest expiring US Patent No. 7,772,2434-phenylamino-quinazolin-6-yl-amides ODE-213INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR (EGFR) EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST |
| Veloxis Pharms Inc. | Envarsus Xr (RX) 3 products | Jul 10, 2015 | Aug 30, 2028 | 23 patentsLatest expiring US Patent No. 8,664,239Tacrolimus for improved treatment of transplant patients |
| Taro | Topicort (RX) | Apr 11, 2013 | Sep 01, 2028 | 2 patentsLatest expiring US Patent No. 8,277,780Stable liquid desoximethasone compositions with reduced oxidized impurity |
| Bayer Healthcare | Nexavar (RX) | Dec 20, 2005 | Sep 10, 2028 | 2 patentsLatest expiring US Patent No. 9,737,488Pharmaceutical composition for the treatment of cancer |
| GE Healthcare | Vizamyl (RX) | Oct 25, 2013 | Sep 16, 2028 | 3 patentsLatest expiring US Patent No. 8,916,131Radiopharmaceutical composition |
| UCB Inc. | Keppra Xr (RX) 2 products | Sep 12, 2008 | Sep 17, 2028 | 1 patentLatest expiring US Patent No. 7,858,122Extended release formulation of levetiracetam |
| Haleon US Holdings | Flonase Sensimist Allergy Relief (OTC) | Aug 02, 2016 | Oct 15, 2028 | 4 patentsLatest expiring US Patent No. 8,147,461Fluid dispensing device |
| Pierre Fabre | Hemangeol (RX) | Mar 14, 2014 | Oct 16, 2028 | 2 patentsLatest expiring US Patent No. 8,338,489Use of a beta blocker for the manufacture of a medicament for the treatment of hemangiomas |
| Teva Branded Pharm | Seasonique (RX) | May 25, 2006 | Dec 05, 2028 | 2 patentsLatest expiring US Patent No. 7,855,190Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration |
| Teva Branded Pharm | Loseasonique (RX) | Oct 24, 2008 | Dec 05, 2028 | 1 patentLatest expiring US Patent No. 7,855,190Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration |
| Lupin Ltd. | Suprax (RX) | Feb 20, 2013 | Dec 14, 2028 | 1 patentLatest expiring US Patent No. 9,233,112Pharmaceutical compositions of cefixime |
| Genentech | Erivedge (RX) | Jan 30, 2012 | Dec 15, 2028 | 3 patentsLatest expiring US Patent No. 9,278,961Pyridyl inhibitors of hedgehog signalling |
| Impax | Rytary (RX) 4 products | Jan 07, 2015 | Dec 26, 2028 | 8 patentsLatest expiring US Patent No. 8,377,474Controlled release formulations of levodopa and uses thereof |
| Merck Sharp Dohme | Prevymis (RX) 2 products | Nov 08, 2017 | Jan 18, 2029 | 2 patentsPatent reissue RE46791Substituted dihydroquinazolines NPPNEW PATIENT POPULATION |
| Msd | Prevymis (RX) 2 products | Aug 30, 2024 | Jan 18, 2029 | 1 patentPatent reissue RE46791Substituted dihydroquinazolines NPNEW PRODUCT |
| Msd Sub Merck | Janumet (RX) 2 products | Mar 30, 2007 | Jan 21, 2029 | 2 patentsLatest expiring US Patent No. 8,414,921Pharmaceutical compositions of combinations of dipeptidyl peptidase-4 inhibitors with metformin PEDPEDIATRIC EXCLUSIVITY |
| Sandoz | Angiomax (RX) | Dec 15, 2000 | Jan 27, 2029 | 2 patentsLatest expiring US Patent No. 7,582,727Pharmaceutical formulations of bivalirudin and processes of making the same |
| Cardinal Health 414 | Lymphoseek Kit (RX) | Mar 13, 2013 | Jan 30, 2029 | 2 patentsLatest expiring US Patent No. 9,439,985Compositions for radiolabeling diethylenetriaminepentaacetic acid (DTPA)-dextran NPPNEW PATIENT POPULATION |
| Apil | Lo Loestrin Fe (RX) | Oct 21, 2010 | Feb 02, 2029 | 1 patentLatest expiring US Patent No. 7,704,984Extended estrogen dosing contraceptive regimen |
| Takeda Pharms USA | Actoplus Met (RX) | Aug 29, 2005 | Feb 03, 2029 | 2 patentsLatest expiring US Patent No. 9,320,714Tablet |
| Bausch And Lomb | Vyzulta (RX) | Nov 02, 2017 | Feb 21, 2029 | 4 patentsLatest expiring US Patent No. 8,058,467Prostaglandin derivatives |
| Assertio | Zipsor (RX) | Jun 16, 2009 | Feb 24, 2029 | 6 patentsLatest expiring US Patent No. 7,662,858Method of treating post-surgical acute pain NPPNEW PATIENT POPULATION |
| Janssen Pharms | Invokamet Xr (RX) 4 products | Sep 20, 2016 | Feb 26, 2029 | 5 patentsLatest expiring US Patent No. 7,943,582Crystalline form of 1-(β-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate |
| Leo Pharma A/S | Finacea (RX) | Jul 29, 2015 | Feb 28, 2029 | 5 patentsLatest expiring US Patent No. 9,211,259Antibiotic kit and composition and uses thereof |
| Teva Branded Pharm | Quartette (RX) | Mar 28, 2013 | Mar 11, 2029 | 2 patentsLatest expiring US Patent No. 8,415,332Methods of hormonal treatment utilizing ascending-dose extended cycle regimens |
| Clivunel Inc. | Scenesse (RX) | Oct 08, 2019 | Mar 11, 2029 | 2 patentsLatest expiring US Patent No. 8,334,265Method of treatment of photodermatoses NCENEW CHEMICAL ENTITY |
| Pohl Boskamp | Nitrolingual Pumpspray (RX) | Jan 10, 1997 | Mar 12, 2029 | 1 patentLatest expiring US Patent No. 7,872,049Long-term stable pharmaceutical preparation containing the active ingredient glyceryl trinitrate |
| Italfarmaco SA | Tiglutik Kit (RX) | Sep 05, 2018 | Mar 12, 2029 | 1 patentLatest expiring US Patent No. 8,765,150Riluzole aqueous suspensions |
| Baxter Healthcare | Nexterone (RX) 2 products | Nov 16, 2010 | Mar 13, 2029 | 1 patentLatest expiring US Patent No. 7,635,773Sulfoalkyl ether cyclodextrin compositions |
| Covis | Tudorza Pressair (RX) | Jul 23, 2012 | Mar 13, 2029 | 4 patentsLatest expiring US Patent No. 10,085,974Dosage and formulation |
| Covis | Duaklir Pressair (RX) | Mar 29, 2019 | Mar 13, 2029 | 4 patentsLatest expiring US Patent No. 10,085,974Dosage and formulation |
| Life Molecular | Neuraceq (RX) | Mar 19, 2014 | Mar 18, 2029 | 1 patentLatest expiring US Patent No. 7,807,135Stilbene derivatives and their use for binding and imaging amyloid plaques |
| Janssen Therap | Sirturo (RX) 2 products | Dec 28, 2012 | Mar 19, 2029 | 2 patentsLatest expiring US Patent No. 8,546,428Fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol M-306REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF A CLINICAL STUDY TO FULFILL POST MARKETING REQUIREMENT 1988-001 |
| Collegium Pharm Inc. | Nucynta Er (RX) 5 products | Aug 25, 2011 | Mar 22, 2029 | 4 patentsLatest expiring US Patent No. 8,536,130Use of 1 phenyl-3-dimethylamino-propane compounds for treating neuropathic pain |
| Incyte Corp. | Jakafi (RX) 5 products | Nov 16, 2011 | Mar 22, 2029 | 8 patentsLatest expiring US Patent No. 10,016,429Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile PEDPEDIATRIC EXCLUSIVITY |
| Astrazeneca | Koselugo (RX) 2 products | Apr 10, 2020 | Mar 26, 2029 | 5 patentsLatest expiring US Patent No. 11,813,246Pharmaceutical composition ODE-288INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN) |
| Neurelis Inc. | Valtoco (RX) 3 products | Jan 10, 2020 | Mar 27, 2029 | 6 patentsLatest expiring US Patent No. 11,241,414Administration of benzodiazepine compositions ODE-279INDICATED FOR THE ACUTE TX OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E. SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT’S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 6 YEARS OF AGE AND OLDER |
| United Therap | Remodulin (RX) 8 products | May 21, 2002 | Mar 29, 2029 | 9 patentsLatest expiring US Patent No. 7,999,007Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same |
| Aytu | Karbinal Er (RX) | Mar 28, 2013 | Mar 29, 2029 | 2 patentsLatest expiring US Patent No. 8,062,667Modified release formulations containing drug-ion exchange resin complexes |
| Legacy Pharma | Brisdelle (RX) | Jun 28, 2013 | Apr 06, 2029 | 4 patentsLatest expiring US Patent No. 8,658,663Method of treating thermoregulatory disfunction with paroxetine |
| Actelion | Opsumit (RX) | Oct 18, 2013 | Apr 18, 2029 | 5 patentsLatest expiring US Patent No. 8,268,847Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor |
| Ultragenyx Pharm Inc. | Dojolvi (RX) | Jun 30, 2020 | Apr 28, 2029 | 2 patentsLatest expiring US Patent No. 8,697,748Glycogen or polysaccharide storage disease treatment method NCENEW CHEMICAL ENTITY |
| Bristol-Myers | Vidaza (RX) | May 19, 2004 | May 20, 2029 | ODE-399TREATMENT OF PEDIATRIC PATIENTS AGED ONE MONTH AND OLDER WITH NEWLY DIAGNOSED JUVENILE MYELOMONOCYTIC LEUKEMIA (JMML) |
| Mobius Therap | Mitosol (RX) | Feb 07, 2012 | May 21, 2029 | 5 patentsLatest expiring US Patent No. 9,649,428Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application |
| Takeda Pharms USA | Kazano (RX) 2 products | Jan 25, 2013 | May 24, 2029 | 4 patentsLatest expiring US Patent No. 8,900,638Solid preparation comprising alogliptin and metformin hydrochloride M-300REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY SYR-322-309, CONDUCTED IN RESPONSE TO A PEDIATRIC WRITTEN REQUEST |
| Thea Pharma | Zioptan (RX) | Feb 10, 2012 | May 28, 2029 | 2 patentsLatest expiring US Patent No. 10,864,159Method and composition for treating ocular hypertension and glaucoma |
| Medexus | Rasuvo (RX) 9 products | Jul 10, 2014 | Jun 01, 2029 | 1 patentLatest expiring US Patent No. 8,664,231Concentrated methotrexate solutions |
| Harrow Eye | Verkazia (RX) | Jun 23, 2021 | Jun 02, 2029 | 7 patentsLatest expiring US Patent No. 9,132,071Compositions containing quaternary ammonium compounds NPNEW PRODUCT |
| Mallinckrodt Hosp | Inomax (RX) | Jan 17, 2023 | Jun 03, 2029 | 1 patentLatest expiring US Patent No. 11,931,377Methods of administering inhaled nitric oxide gas |
| Takeda Pharms USA | Oseni (RX) 4 products | Jan 25, 2013 | Jun 04, 2029 | 4 patentsLatest expiring US Patent No. 8,637,079Solid preparation comprising alogliptin and pioglitazone |
| Azurity | Horizant (RX) 2 products | Apr 06, 2011 | Jun 10, 2029 | 5 patentsLatest expiring US Patent No. 8,795,725GABA analog prodrug sustained release oral dosage forms |
| Haleon US Holdings | Nicorette (OTC) 2 products | May 18, 2009 | Jun 14, 2029 | 2 patentsLatest expiring US Patent No. 8,501,164Nicotine lozenge compositions |
| Vivus LLC | Qsymia (RX) 4 products | Jul 17, 2012 | Jun 14, 2029 | 6 patentsLatest expiring US Patent No. 8,580,299Escalating dosing regimen for effecting weight loss and treating obesity NPPNEW PATIENT POPULATION |
| Takeda Pharms USA | Nesina (RX) 3 products | Jan 25, 2013 | Jun 16, 2029 | 4 patentsLatest expiring US Patent No. 8,697,125Tablet preparation without causing a tableting trouble M-300REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY SYR-322-309, CONDUCTED IN RESPONSE TO A PEDIATRIC WRITTEN REQUEST |
| Otsuka | Rexulti (RX) | Jul 10, 2015 | Jun 23, 2029 | 5 patentsPatent reissue RE48059Piperazine-substituted benzothiophenes for treatment of mental disorders PEDPEDIATRIC EXCLUSIVITY |
| Verity | Trelstar (RX) | Mar 10, 2010 | Jun 30, 2029 | 1 patentLatest expiring US Patent No. 10,166,181Slow release pharmaceutical composition made of microgranules |
| Azurity | Triptodur Kit (RX) | Jun 29, 2017 | Jun 30, 2029 | 1 patentLatest expiring US Patent No. 10,166,181Slow release pharmaceutical composition made of microgranules ODE-149TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH CENTRAL PRECOCIOUS PUBERTY |
| Helsinn | Valchlor (RX) | Aug 23, 2013 | Jul 08, 2029 | 6 patentsLatest expiring US Patent No. 7,872,050Stabilized compositions of volatile alkylating agents and methods of using thereof |
| Viiv Healthcare | Rukobia (RX) | Jul 02, 2020 | Jul 13, 2029 | 3 patentsLatest expiring US Patent No. 8,168,615Prodrugs of piperazine and substituted piperidine antiviral agents NCENEW CHEMICAL ENTITY |
| Salix Pharms | Xifaxan (RX) | May 25, 2004 | Jul 24, 2029 | 14 patentsLatest expiring US Patent No. 7,928,115Methods of treating travelers diarrhea and hepatic encephalopathy |
| Bausch | Acanya (RX) | Oct 23, 2008 | Aug 05, 2029 | 6 patentsLatest expiring US Patent No. 8,288,434Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent |
| Bausch | Onexton (RX) | Nov 24, 2014 | Aug 05, 2029 | 5 patentsLatest expiring US Patent No. 8,288,434Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent |
| Sun Pharm | Bromsite (RX) | Apr 08, 2016 | Aug 07, 2029 | 1 patentLatest expiring US Patent No. 8,778,999Non-steroidal anti-inflammatory ophthalmic compositions |
| Vertex Pharms | Kalydeco (RX) | Jan 31, 2012 | Aug 13, 2029 | 9 patentsLatest expiring US Patent No. 10,646,481Pharmaceutical composition and administrations thereof ODE-338FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 4 MONTHS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 21, 2020 |
| Mylan Ireland Ltd. | Pretomanid (RX) | Aug 14, 2019 | Aug 14, 2029 | GAINGENERATING ANTIBIOTIC INCENTIVES NOW |
| Abbvie | Acuvail (RX) | Jul 22, 2009 | Aug 15, 2029 | 4 patentsLatest expiring US Patent No. 7,842,714Ketorolac tromethamine compositions for treating ocular pain |
| Nabriva | Xenleta (RX) | Aug 19, 2019 | Aug 19, 2029 | 2 patentsLatest expiring US Patent No. 8,071,643Pleuromutilin derivatives for the treatment of diseases mediated by microbes GAINGENERATING ANTIBIOTIC INCENTIVES NOW |
| Takeda Pharms USA | Mydayis (RX) 4 products | Jun 20, 2017 | Aug 24, 2029 | 2 patentsLatest expiring US Patent No. 8,846,100Controlled dose drug delivery system |
| Msd Sub Merck | Isentress (RX) 2 products | Dec 21, 2011 | Sep 11, 2029 | 2 patentsLatest expiring US Patent No. 7,754,731Potassium salt of an HIV integrase inhibitor |
| Bayer Healthcare | Mirena (RX) | Dec 06, 2000 | Sep 16, 2029 | 2 patentsLatest expiring US Patent No. 10,561,524Inserter |
| Bayer Healthcare | Skyla (RX) | Jan 09, 2013 | Sep 16, 2029 | 3 patentsLatest expiring US Patent No. 10,561,524Inserter |
| Bayer Healthcare | Kyleena (RX) | Sep 16, 2016 | Sep 16, 2029 | 3 patentsLatest expiring US Patent No. 10,561,524Inserter |
| Abbvie | Vraylar (RX) 4 products | Sep 17, 2015 | Sep 17, 2029 | 5 patentsLatest expiring US Patent No. 7,737,142(Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists I-904ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER IN ADULTS |
| Novartis | Tykerb (RX) | Mar 13, 2007 | Sep 18, 2029 | 1 patentLatest expiring US Patent No. 8,821,927Pharmaceutical composition |
| Abbvie | Savella (RX) 4 products | Jan 14, 2009 | Sep 19, 2029 | 1 patentLatest expiring US Patent No. 7,994,220Milnacipran for the long-term treatment of fibromyalgia syndrome |
| Zevra Denmark | Miplyffa (RX) 4 products | Sep 20, 2024 | Sep 20, 2029 | 3 patentsLatest expiring US Patent No. 11,045,460Use of Hsp70 as a regulator of enzymatic activity NCENEW CHEMICAL ENTITY |
| Salix Pharms | Xifaxan (RX) | Mar 24, 2010 | Oct 02, 2029 | 28 patentsLatest expiring US Patent No. 8,642,573Methods of treating hepatic encephalopathy |
| Astrazeneca | Symbicort (RX) 2 products | Jul 21, 2006 | Oct 07, 2029 | 5 patentsLatest expiring US Patent No. 8,616,196Inhalation device and a method for assembling said inhalation device |
| Tersera | Varubi (RX) | Sep 01, 2015 | Oct 09, 2029 | 7 patentsLatest expiring US Patent No. 8,361,500Tablet formulations containing 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one salts and tablets made therefrom |
| Sandoz | Travatan Z (RX) | Sep 21, 2006 | Oct 13, 2029 | 3 patentsLatest expiring US Patent No. 8,268,299Self preserved aqueous pharmaceutical compositions |
| Alkermes | Vivitrol (RX) | Apr 13, 2006 | Oct 15, 2029 | 1 patentLatest expiring US Patent No. 7,919,499Naltrexone long acting formulations and methods of use |
| Chiesi | Ferriprox (RX) | Sep 09, 2015 | Oct 26, 2029 | 1 patentLatest expiring US Patent No. 8,703,156Liquid formulation for deferiprone with palatable taste ODE-418TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH THALASSEMIA SYNDROMES |
| Kaleo Inc. | Auvi-Q (RX) | Aug 10, 2012 | Nov 02, 2029 | 14 patentsLatest expiring US Patent No. 8,021,344Medicament delivery device configured to produce an audible output |
| Pf Prism Cv | Xalkori (RX) 5 products | Aug 26, 2011 | Nov 06, 2029 | 5 patentsLatest expiring US Patent No. 8,217,057Polymorphs of a c-MET/HGFR inhibitor I-897TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH UNRESECTABLE, RECURRENT OR REFRACTORY INFLAMMATORY MYOFIBROBLASTIC TUMOR (IMT) THAT IS ANAPLASTIC LYMPHOMA KINASE (ALK) POSITIVE |
| Syndax | Revuforj (RX) 3 products | Nov 15, 2024 | Nov 15, 2029 | NCENEW CHEMICAL ENTITY |
| Takeda Pharms USA | Ninlaro (RX) 3 products | Nov 20, 2015 | Nov 20, 2029 | 9 patentsLatest expiring US Patent No. 7,442,830Proteasome inhibitors |
| Abbvie | Namzaric (RX) 4 products | Dec 23, 2014 | Dec 05, 2029 | 9 patentsLatest expiring US Patent No. 8,058,291Methods and compositions for the treatment of CNS-related conditions |
| Boehringer Ingelheim | Ofev (RX) 2 products | Oct 15, 2014 | Dec 07, 2029 | 5 patentsLatest expiring US Patent No. 9,907,756Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative PEDPEDIATRIC EXCLUSIVITY |
| Bausch | Zyclara (RX) | Jul 15, 2011 | Dec 11, 2029 | 2 patentsLatest expiring US Patent No. 11,318,1302x2x2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75% imiquimod |
| Jazz | Zepzelca (RX) | Jun 15, 2020 | Dec 13, 2029 | 1 patentLatest expiring US Patent No. 7,763,615Ecteinascidin analogs for use as antitumour agents ODE-304INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC SMALL CELL LUNG CANCER (SCLC) WITH DISEASE PROGRESSION ON OR AFTER PLATINUM-BASED CHEMOTHERAPY |
| Harrow Eye | Triesence (RX) | Nov 29, 2007 | Dec 17, 2029 | 2 patentsLatest expiring US Patent No. 8,128,960Low viscosity, highly flocculated triamcinolone acetonide suspensions for intravitreal injection |
Note Data shown from December 2024 through 2029. If you're interested in the full data, please reach out!
Data Source and Provenance
The Orange Book is updated by FDA once per month (usually by the 16th) with data from the previous month. Consider the database "Current" when it lags one month behind the current date (e.g., in December, a November update should be considered current).
This dataset is from an internal database generated by harmonizing data from the FDA Orange Book with USPTO patent data summarized by USPTO's PatentsView. We calculate the "Estimated End of Exclusivity" by considering the later of the FD&C Exclusivity expiration and the latest patent expiration. Details about the specific exclusivity claimed and/or patents are included in the table. For brevity, we are only including details about the latest expiring patent claimed.
Database Last updated: Nov 2024
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