PEGINTERFERON ALFA-2B | B103949 | SCHERING
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Jan. 19, 2001 — 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 10519194· AI-discovered, not Purple-Book-listed · relevance 50/100. This caps practical skinny-label entry; it does not move the licensure floor above.
6 formulation/compound (cap skinny entry) · 4 method-of-use (carveable — gate nothing) · 1 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 10519194 | Formulation/compound | Dec. 26, 2039Active | Discovered |
| 8535887 | Other | Sep. 12, 2033Active | Discovered |
| 7670595 | Formulation/compound | Feb. 25, 2030Active | Discovered |
| 7632491 | Formulation/compound | Dec. 10, 2029Active | Discovered |
| 7615615 | Formulation/compound | Nov. 5, 2029Active | Discovered |
| 7579440 | Formulation/compound | Aug. 20, 2029Active | Discovered |
| 7456257 | Formulation/compound | Nov. 20, 2028Active | Discovered |
| 6685931 | Method-of-use (carveable) | Jan. 29, 2024Expired | Discovered |
| 6605273 | Method-of-use (carveable) | Aug. 7, 2023Expired | Discovered |
| 6362162 | Method-of-use (carveable) | Mar. 21, 2022Expired | Discovered |
| 6172046 | Method-of-use (carveable) | Jan. 4, 2021Expired | Discovered |
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.
11 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.