# FDA Exclusivity Export — Evaluation Sample — 2026-04

**Generated:** 2026-05-19

> **Evaluation use only.** This sample is provided under the [RxDataLab Terms of Service](https://rxdatalab.com/terms-of-service). You may use it solely to evaluate whether this dataset meets your needs. Commercial use, redistribution, sublicensing, and incorporation into any product or workflow are not permitted. Contact info@rxdatalab.com to license the full dataset.

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## This is a Sample

This bundle contains a curated subset of the full FDA Exclusivity Export:

| Source | This sample | Full dataset |
|--------|-------------|-------------|
| Orange Book (NDA) | 27,121 | ~5,500 |
| Purple Book (BLA) | 841 | ~840 |
| Generic applications (ANDA) | Not included | ~22,000 |

NDAs were selected to span all approval eras (2020s through pre-2000) and to demonstrate the full range of patent and exclusivity data. BLAs span reference products, biosimilars, and interchangeable biologics.

**Known limitation — `first_generic_entry` is empty in this sample.** The full dataset includes ~2,400 NDA formulations with at least one approved generic. In this sample, ANDA (generic) applications are not included, so the `first_generic_entry` view and the "Products that have lost exclusivity" example query return 0 rows. This is a deliberate sample scoping decision, not a data quality issue. See `EXAMPLES.sql` for details.

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## Contents

| File | Description |
|------|-------------|
| `fda_exclusivity.db` | Primary SQLite database — all tables, history, and derived views |
| `AGENTS.md` | Field-by-field documentation for AI/LLM consumers |
| `EXAMPLES.sql` | Ready-to-run analysis queries (adapted for sample scope) |
| `csv/` | One CSV per table and view |

## Current Snapshot

| Source | FDA Release | Applications | Products |
|--------|-------------|--------------|----------|
| Orange Book (NDA/ANDA) | EOBZIP_2026_04 | 27,121 | 48,215 |
| Purple Book (BLA) | PB_2026_01 | 841 | 2,182 |

Drug labels (SPL): 3,019 | Indication coverage (NDA): ~55% | RxDataLab-matched companies: 308

## Change History Depth

The sample retains the full change history for the selected applications — depth reflects the full production dataset.

| Source | Table type | Months tracked | Range |
|--------|-----------|---------------|-------|
| Orange Book | Products / exclusivity | 30 | 2023-10-01 to 2026-04-01 |
| Orange Book | Patents | 30 | (subset of above) |
| Purple Book | Products / applications / exclusivity | 72 | 2020-05-01 to 2026-04-01 |
| Purple Book | Patents | 1 | (subset of above) |

## Key Tables

**Orange Book (small-molecule NDA/ANDA):**
- `ob_applications` — FDA application registry with sponsor and RxDataLab company identity
- `ob_products` — Drug products (ingredient, route, strength, TE code)
- `ob_patents` — Listed patents with expiry, substance/product flags, and pediatric extension indicator
- `ob_exclusivity` — Market exclusivity grants by code and expiration date
- `ob_*_changes` — Full SCD change history for each table

**Purple Book (biologics BLA):**
- `pb_applications` — BLA registry with sponsor and RxDataLab company identity
- `pb_products` — Biologic products (proprietary name, proper name, license type, marketing status)
- `pb_exclusivity` — Exclusivity grants (standard 12yr, orphan 7yr, first_interchangeable, ref_product)
- `pb_patents` — Listed patents (sparse — only a small fraction of BLAs list patents)
- `pb_*_changes` — Full SCD change history

**Shared:**
- `drug_labels` — SPL label data covering both NDA and BLA application numbers
- `patent_details` — PatentsView title/grant date enrichment for OB-listed patents

**Derived Views:**
- `ob_loe_estimates` — Loss-of-exclusivity cliff per NDA (patent PED-adjusted)
- `pb_loe_estimates` — LOE per BLA reference product (standard + ref_product + orphan exclusivity)
- `all_loe_estimates` — Combined NDA + BLA LOE calendar
- `all_applications` — Unified NDA + BLA portfolio view (excludes ANDAs)
- `first_generic_entry` — **Empty in this sample** (ANDA data not included; see above)

## RxDataLab Company Identity

The `rxdl_company`, `rxdl_ticker`, `rxdl_cik`, and `rxdl_company_id` columns in `ob_applications` and `pb_applications` are RxDataLab-curated sponsor-to-company mappings.

- `rxdl_company` is the canonical company name — use it as the join key across `ob_applications` and `pb_applications`.
- `rxdl_company_id` is an integer primary key if you need stable joins across the full RxDataLab dataset.

## LOE Methodology

`reported_loe_date` is the latest of the adjusted patent expiry and exclusivity expiration.

- Patent PED adjustment: +6 months when `pediatric_excl = 1` (only in OB patents)
- PB LOE uses `standard`, `ref_product` (both represent 12yr BPCIA), and `orphan` (7yr) exclusivity types; `first_interchangeable` is excluded (protects biosimilar sponsors, not reference products)
- `years_to_loe` is computed at export generation time — recalculate from `reported_loe_date` for current values

**Disclaimers:** Does not account for patent maintenance fee lapse, patent term adjustments (PTA), Paragraph IV challenges, or regulatory decisions after the export date.

## Patent Caveats

**Orange Book patents** are well-tracked. The OB has required patent listing since Hatch-Waxman (1984) and the FDA publishes monthly updates.

**Purple Book patents** are sparse and have shorter change history:
- FDA patent listing under BPCIA is limited to a small subset of BLAs. Most BLAs have no listed patents in the Purple Book.
- For biologics competitive intelligence, exclusivity dates (not patents) are the primary LOE signal. Use `pb_loe_estimates`.

## Questions and Licensing

To license the full dataset or discuss custom data needs, contact: info@rxdatalab.com

Terms of service: https://rxdatalab.com/terms-of-service
