EPTINEZUMAB-JJMR | B761119 | Lundbeck Seattle BioPharmaceuticals, Inc.
Earliest legal licensure (12-year BPCIA floor)
The 12-year reference-product exclusivity is the non-carveable floor — the earliest FDA could license a biosimilar for any indication. Unverified estimate — derived from the earliest available approval record (Feb. 21, 2020), not an FDA-stated exclusivity date. Shown with lower confidence than a Purple Book value.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | Feb. 21, 2032 | 5y 7mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Feb. 21, 2032 | 5y 7mo remaining | 12-year RPE floor |
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 12030923(composition)· AI-discovered, not Purple-Book-listed · relevance 50/100. This caps practical skinny-label entry; it does not move the licensure floor above.
19 formulation/compound (cap skinny entry) · 2 method-of-use (carveable — gate nothing) · 17 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12385913 | Other | Aug. 7, 2045Active | Discovered |
| 12325875 | Other | Jun. 5, 2045Active | Discovered |
| 12241107 | Other | Feb. 27, 2045Active | Discovered |
| 12234483 | Other | Feb. 20, 2045Active | Discovered |
| 12157073 | Other | Nov. 28, 2044Active | Discovered |
| 12085564 | Other | Sep. 5, 2044Active | Discovered |
| 12030923 | Formulation/compound | Jul. 4, 2044Active | Discovered |
| 11787860 | Formulation/compound | Oct. 12, 2043Active | Discovered |
| 11603406 | Formulation/compound | Mar. 9, 2043Active | Discovered |
| 11542337 | Formulation/compound | Dec. 29, 2042Active | Discovered |
| 11427632 | Formulation/compound | Aug. 25, 2042Active | Discovered |
| 11312777 | Formulation/compound | Apr. 21, 2042Active | Discovered |
| 10738078 | Other | Aug. 6, 2040Active | Discovered |
| 10590457 | Other | Mar. 12, 2040Active | Discovered |
| 10448622 | Formulation/compound | Oct. 17, 2039Active | Discovered |
Showing 15 of 38 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.
38 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.