FDA Purple Book
Licensed biological products, their biosimilars, and when their exclusivity ends. Switch to the table view for every column in a full-screen grid.
Loading Purple Book summary…
Loading explorer...
Licensed biological products, their biosimilars, and when their exclusivity ends. Switch to the table view for every column in a full-screen grid.
Licensed products
940
across 2,485 presentations
Biosimilars
94
39 interchangeable
Biologic substances
663
71% of licences
Licence holders
282
3.3 licences each
Exclusivity expiring
207
within five years
Source: FDA Purple Book, published monthly · data as of Sep 1, 2026
Licences (BLAs), each counted once. Every BLA is a 351(a) originator or a 351(k) follow-on; a 351(k) licence with any interchangeable presentation counts as interchangeable.
◯ pill: entry▭ box: state◇ diamond: decision⬭ bold: outcome⬭ dashed: left the path
Product presentations (one strength in one container), not licences: CDER (drugs) and CBER (biologics)
| 1,428 | 57.5% | |
| 1,057 | 42.5% |
Product presentations, not licences: one licence can have presentations in several statuses