INTERFERON ALFA-2B | B103132 | SCHERING
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Jun. 4, 1986 — 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 | Nov. 21, 1995 | 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 12168683(composition)· AI-discovered, not Purple-Book-listed · relevance 68/100. This caps practical skinny-label entry; it does not move the licensure floor above.
19 formulation/compound (cap skinny entry) · 6 method-of-use (carveable — gate nothing) · 8 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12168683 | Formulation/compound | Dec. 12, 2044Active | Discovered |
| 12042524 | Formulation/compound | Jul. 18, 2044Active | Discovered |
| 11590434 | Other | Feb. 23, 2043Active | Discovered |
| 11116911 | Other | Sep. 9, 2041Active | Discovered |
| 11104721 | Formulation/compound | Aug. 26, 2041Active | Discovered |
| 10563163 | Other | Feb. 13, 2040Active | Discovered |
| 10429129 | Formulation/compound | Sep. 26, 2039Active | Discovered |
| 9644015 | Other | May. 4, 2037Active | Discovered |
| 9522174 | Formulation/compound | Dec. 15, 2036Active | Discovered |
| 9452106 | Formulation/compound | Sep. 22, 2036Active | Discovered |
| 9399757 | Other | Jul. 21, 2036Active | Discovered |
| 9096879 | Other | Jul. 30, 2035Active | Discovered |
| 8932574 | Formulation/compound | Jan. 8, 2035Active | Discovered |
| 8784399 | Formulation/compound | Jul. 17, 2034Active | Discovered |
| 8562967 | Formulation/compound | Oct. 17, 2033Active | Discovered |
Showing 15 of 33 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.
33 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.