PatentCliff: Generic & Biosimilar Entry Radar
PatentCliff tracks computed loss-of-exclusivity dates for 1,375 brand drugs, joined from FDA Orange Book, Purple Book, and Paragraph IV filings as of 2026-07-03.
- Records
- 1,375 brands with a computed LOE date; 3,068 Paragraph IV records; 228 licensed biosimilars
- Sources
- 3 free, keyless FDA sources (Orange Book, Purple Book, Paragraph IV list)
- History depth
- Full current Orange Book and Purple Book listings; live LOE horizon
- Update cadence
- Monthly (Orange Book, Purple Book); as FDA posts new Paragraph IV filings
- Delivery format
- CSV, JSON, and Excel exports; SQLite database on request
- License
- Commercial license after signed agreement; underlying FDA data is public domain
- Sample availability
- Gated preview below; full sample by request
Coverage & headline figures
Built from three free, keyless FDA sources and joined deterministically on NDA/BLA number and ingredient into one scored, exportable LOE calendar. Snapshot 2026-07-03, live FDA data.
Also in the join: 2,265 Orange Book exclusivity grants, 2,205 licensed biologics, and 1,198 brands already under an active Paragraph IV generic challenge (1,206 distinct NDAs on the PIV list). Deepest biosimilar benches: adalimumab (54) · ustekinumab (35) · denosumab (21) · filgrastim (16). Mean row quality score 0.92 across dated LOE rows.
Brand-drug patent expirations crest in year three of the five-year LOE window: 99 brands losing exclusivity 25–36 months out
Humira has more licensed biosimilar competitors than any other reference biologic: 54, ahead of Stelara’s 35
Sources (all free, keyless, public-domain)
-
FDA Orange Book (monthly EOB ZIP,
~-delimited.txt) → every listed patent and exclusivity code per NDA product. - FDA Purple Book (monthly CSV) → biologic exclusivity plus licensed biosimilars per BLA.
- FDA Paragraph IV certifications (PDF) → which brand drugs already face generic challengers, extracted from the PDF text layer with no OCR.
What’s in it: schema
Three cross-linked exports. loe_calendar is the
headline deliverable: one row per brand drug with its
computed cliff date. piv_watchlist and
biosimilar_pipeline carry the challenge-level and
biologic-level detail that feed it.
| Table | Grain (one row =) | Notable columns | Rows |
|---|---|---|---|
| loe_calendar | one brand drug (NDA) | loe_date, months_remaining, has_active_piv, evergreening_count, quality_score | 1,375 |
| piv_watchlist | one Paragraph IV certification record | first_piv_date, last_qualifying_patent_expiry, months_remaining | 3,068 |
| biosimilar_pipeline | one reference biologic (BLA) | exclusivity_exp_date, biosimilar_count | 567 |
Source: FDA Orange Book, Purple Book, and Paragraph IV list, extracted 2026-07-03.
Columns in loe_calendar (the headline table)
Columns in piv_watchlist (challenge-level detail)
Sample preview gated
A representative slice of the LOE calendar, showing recognizable brands approaching their cliff. Ingredient, applicant, NDA number, active patent count, and evergreening count are shown. The computed LOE date, the months of runway, and the Paragraph IV challenge status (the proprietary, sellable columns) are redacted. Seven of 1,375 brands shown; ordering does not reflect the LOE calendar.
| Brand | Ingredient | Applicant | NDA | Active patents | Evergreened | LOE date† | Runway (mo)† | PIV challenge† |
|---|---|---|---|---|---|---|---|---|
| SPRYCEL | Dasatinib | Bristol Myers Squibb | 021986 | 2 | 0 | withheld | withheld | withheld |
| SPIRIVA | Tiotropium bromide | Boehringer Ingelheim | 021395 | 2 | 1 | withheld | withheld | withheld |
| ANDROGEL | Testosterone | Besins Healthcare | 022309 | 8 | 8 | withheld | withheld | withheld |
| SENSIPAR | Cinacalcet hydrochloride | Amgen | 021688 | 2 | 2 | withheld | withheld | withheld |
| VYNDAQEL | Tafamidis meglumine | FoldRx Pharms | 211996 | 2 | 2 | withheld | withheld | withheld |
| PROTONIX | Pantoprazole sodium | Wyeth Pharms | 022020 | 2 | 0 | withheld | withheld | withheld |
| DUEXIS | Famotidine; ibuprofen | Horizon | 022519 | 5 | 5 | withheld | withheld | withheld |
Source: FDA Orange Book and Paragraph IV certifications (FDA.gov), extracted 2026-07-03. 7 of 1,375 brands shown; ordering does not reflect the LOE calendar.
† The computed LOE date, runway in months, and Paragraph IV challenge status are withheld pending license.
Request the full live sample
Get a live, end-to-end sample of PatentCliff: the full
loe_calendar with computed LOE dates, runway, and
Paragraph IV challenge flags, plus the PIV watchlist, the
biosimilar pipeline, the monthly change-feed, and methodology.
No full dataset is downloadable from this page. Public-domain U.S. Government data (FDA Orange Book, Purple Book, Paragraph IV list); not affiliated with the U.S. FDA.