SECUKINUMAB | B761349 | NOVARTIS PHARMS CORP
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 (Oct. 6, 2023), 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) | Oct. 6, 2035 | 9y 2mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Oct. 6, 2035 | 9y 2mo 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 12331104(composition)· AI-discovered, not Purple-Book-listed · relevance 75/100. This caps practical skinny-label entry; it does not move the licensure floor above.
31 formulation/compound (cap skinny entry) · 13 method-of-use (carveable — gate nothing) · 6 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12371510 | Other | Jul. 24, 2045Active | Discovered |
| 12331104 | Formulation/compound | Jun. 12, 2045Active | Discovered |
| 12296008 | Formulation/compound | May. 8, 2045Active | Discovered |
| 12240884 | Method-of-use (carveable) | Feb. 27, 2045Active | Discovered |
| 12209124 | Formulation/compound | Jan. 23, 2045Active | Discovered |
| 12146187 | Method-of-use (carveable) | Nov. 14, 2044Active | Discovered |
| 11999802 | Formulation/compound | May. 30, 2044Active | Discovered |
| 11801300 | Formulation/compound | Oct. 26, 2043Active | Discovered |
| 11639378 | Formulation/compound | Apr. 27, 2043Active | Discovered |
| 11534490 | Method-of-use (carveable) | Dec. 22, 2042Active | Discovered |
| 11534491 | Method-of-use (carveable) | Dec. 22, 2042Active | Discovered |
| 11351253 | Method-of-use (carveable) | Jun. 2, 2042Active | Discovered |
| 11352421 | Method-of-use (carveable) | Jun. 2, 2042Active | Discovered |
| 11292833 | Other | Mar. 31, 2042Active | Discovered |
| 11278618 | Method-of-use (carveable) | Mar. 17, 2042Active | Discovered |
Showing 15 of 50 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.
Top 50 of 259 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.