INTERFERON BETA-1A | B103628 | BIOGEN
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved May. 17, 1996 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | Open now | Open now | no live licensure floor |
| Full-label entry | May. 17, 2003 | Passed | no live block |
Best-skinny equals full-label — no carveable orphan block runs past the licensure floor.
Marketing-entry ceiling (litigation risk)
Patents do not gate FDA licensure of a biosimilar — FDA licenses biosimilars (full or carved label) without adjudicating any patent. These are a practical marketing-entry ceiling resolved in the § 262(l) patent dance and ordinary litigation. A formulation/compound patent caps practical skinny entry via litigation (Regeneron v. Mylan); a method-of-use patent is carveable and gates nothing.
Latest formulation/compound patent 9522174(formulation)· AI-discovered, not Purple-Book-listed · relevance 95/100. This caps practical skinny-label entry; it does not move the licensure floor above.
13 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 30 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 11975293 | Other | May. 2, 2044Active | Discovered |
| 11718864 | Other | Aug. 3, 2043Active | Discovered |
| 11686734 | Other | Jun. 22, 2043Active | Discovered |
| 11617988 | Other | Mar. 30, 2043Active | Discovered |
| 11326185 | Other | May. 5, 2042Active | Discovered |
| 11249026 | Other | Feb. 10, 2042Active | Discovered |
| 11124760 | Other | Sep. 16, 2041Active | Discovered |
| 10961585 | Other | Mar. 25, 2041Active | Discovered |
| 10955422 | Other | Mar. 18, 2041Active | Discovered |
| 10844416 | Other | Nov. 19, 2040Active | Discovered |
| 10738334 | Other | Aug. 6, 2040Active | Discovered |
| 10705095 | Other | Jul. 2, 2040Active | Discovered |
| 10550148 | Other | Jan. 30, 2040Active | Discovered |
| 10500254 | Method-of-use (carveable) | Dec. 5, 2039Active | Discovered |
| 10280436 | Other | May. 2, 2039Active | Discovered |
Showing 15 of 46 patents (latest expirations).
Disclaimer: Identifying an available carve-out is not a prediction that FDA will approve the particular carved label, nor that marketing it is free of infringement risk. For biologics, availability turns on exclusivities, not patents: FDA licenses a biosimilar (full or carved label) without adjudicating any patent, and patent disputes run through the § 262(l) patent dance and ordinary litigation, outside this availability view.
46 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.