INTERFERON BETA-1A | B103780 | SERONO INC
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Mar. 7, 2002 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
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 85/100. This caps practical skinny-label entry; it does not move the licensure floor above.
13 formulation/compound (cap skinny entry) · 4 method-of-use (carveable — gate nothing) · 17 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12441980 | Other | Oct. 9, 2045Active | Discovered |
| 11686734 | Other | Jun. 22, 2043Active | Discovered |
| 10961585 | Other | Mar. 25, 2041Active | Discovered |
| 10955422 | Other | Mar. 18, 2041Active | Discovered |
| 10865224 | Other | Dec. 10, 2040Active | Discovered |
| 10844416 | Other | Nov. 19, 2040Active | Discovered |
| 10705095 | Other | Jul. 2, 2040Active | Discovered |
| 10500254 | Method-of-use (carveable) | Dec. 5, 2039Active | Discovered |
| 9925151 | Method-of-use (carveable) | Mar. 22, 2038Active | Discovered |
| 9644015 | Other | May. 4, 2037Active | Discovered |
| 9562252 | Other | Feb. 2, 2037Active | Discovered |
| 9522174 | Formulation/compound | Dec. 15, 2036Active | Discovered |
| 9452106 | Formulation/compound | Sep. 22, 2036Active | Discovered |
| 9409950 | Formulation/compound | Aug. 4, 2036Active | Discovered |
| 9314534 | Formulation/compound | Apr. 14, 2036Active | Discovered |
Showing 15 of 34 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.
34 AI-discovered patents, sorted by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2010-05-28 | Terminated 2010-10-06 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.