INTERFERON BETA-1B | B103471 | BAYER HEALTHCARE PHARMS
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Jul. 23, 1993 — 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 10689451(formulation)· AI-discovered, not Purple-Book-listed · relevance 58/100. This caps practical skinny-label entry; it does not move the licensure floor above.
5 formulation/compound (cap skinny entry) · 0 method-of-use (carveable — gate nothing) · 7 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 11851666 | Other | Dec. 21, 2043Active | Discovered |
| 11230718 | Other | Jan. 20, 2042Active | Discovered |
| 10961585 | Other | Mar. 25, 2041Active | Discovered |
| 10689451 | Formulation/compound | Jun. 18, 2040Active | Discovered |
| 9994866 | Other | Jun. 7, 2038Active | Discovered |
| 9243224 | Other | Jan. 21, 2036Active | Discovered |
| 7836606 | Other | Nov. 18, 2030Active | Discovered |
| 7662369 | Formulation/compound | Feb. 11, 2030Active | Discovered |
| 7399463 | Formulation/compound | Jul. 10, 2028Active | Discovered |
| 7371373 | Formulation/compound | May. 8, 2028Active | Discovered |
| 6887462 | Formulation/compound | Apr. 28, 2025Expired | Discovered |
| 6284473 | Other | Aug. 30, 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.
12 AI-discovered patents, sorted by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2010-05-28 | Terminated 2010-10-06 | — | |
| D.N.J. | 2010-05-27 | Terminated 2021-03-08 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.