Blog & Research

A sketch diagram of the data pipeline for creating the Drug Exclusivity Dashboard. Displaying the FDA Orange Book and USPTO data as inputs and the dashboard as an output.

Introducing the Drug Exclusivity Dashboard

Published Oct 19, 2024

Drug exclusivity is an important metric to track when monitoring pharma portfolios. RxDataLab has created a dashboard to monitor estimated drug patent and exclusivity expiration in the US.

Plot of Active and Granted Investigational New Drugs (IND). IND receipts and Active IND's rose in 2020.

A Surge in Investigational New Drug Activity

Published Oct 7, 2024

Visualizing the rise in Investigational New Drug (IND) receipts and active INDs during 2019-2020. With no major regulatory changes, the spike appears linked to the COVID-19 pandemic, raising questions about how it shaped drug development.

The logo of RxDataLab. An icon of a microscope looking at pills.

Essential Datasets for Tracking Drug Development from Discovery to Market

Published Sep 27, 2024

The drug development process consists of 5 distinct steps, and there are data sources available to learn more about each step. Here I will cover some of the most important for our work.

Density plot showing the distribution of time to generic approval for drugs approved in 2000 that are still produced

What Proportion of Drugs Approved in 2000 Have Generics in 2024?

Published Sep 15, 2024

81% of drugs approved in 2000 have generic equivalents in 2024. We will dive into how we used the Orange Book to answer this question, and how we approach these problems.

Plot showing the extra exclusivity of drugs with and without the patents challenged by the FTC

FTC Orange Book Patent Challenges

Published Aug 30, 2024

The FTC recently challenged over 100 Orange Book patent listings for drugs including blockbuster Ozempic. In fact, up to 89% of claimed patents were challenged for certain drugs. Here we dive into what was challenged, whether it matters, and what happens now.

Cover of the FDA Orange Book. An orange cover with text on it

FDA Orange Book

Published Aug 10, 2024

The Orange Book, formally known as "Approved Drug Products with Therapeutic Equivalence Evaluations", is a publication that provides consolidated intellectual property, exclusivity information, and therapeutic equivalents for FDA approved brand name drugs.

Simplified org structure of FDA highlighting the CDER organization

What's CDER?

Published Aug 7, 2024

Brief rundown of the Center for Drug Evaluation and Research (CDER), the center that handles approvals and monitoring for new drug applications, generics, and more at FDA.

Diagram illustrating the types of FDA exclusivity and their relative lengths

Drug Exclusivity in the US

Published Aug 3, 2024

Understand the various types of exclusivity and intellectual property protections surround pharmaceutical products in the United States

Plot of GLP1 publications in pubmed showing increasing references of GLP-1. It highligts 2015, when the Novo Nordisk paper was published

The GLP-1 Clinical Trial Landscape in 2024

Published Jul 29, 2024

Glucagon-Like Peptide-1 (GLP-1), Semaglutide, and other GLP-1 targeting drugs are involved in many clinical trials as of July 2024. Here, we cover some of the conditions with active clinical trials that may not be getting as much attention as the weight loss and diabetes cases.