NIVOLUMAB;RELATLIMAB-RMBW | B761234 | BRISTOL MYERS SQUIBB
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 (Mar. 18, 2022), 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) | Mar. 18, 2034 | 7y 8mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Mar. 18, 2034 | 7y 8mo 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 12403174(composition)· AI-discovered, not Purple-Book-listed · relevance 92/100. This caps practical skinny-label entry; it does not move the licensure floor above.
17 formulation/compound (cap skinny entry) · 27 method-of-use (carveable — gate nothing) · 6 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12403174 | Formulation/compound | Aug. 28, 2045Active | Discovered |
| 12258407 | Formulation/compound | Mar. 20, 2045Active | Discovered |
| 12227576 | Method-of-use (carveable) | Feb. 13, 2045Active | Discovered |
| 12207628 | Formulation/compound | Jan. 23, 2045Active | Discovered |
| 12152067 | Formulation/compound | Nov. 21, 2044Active | Discovered |
| 12152075 | Method-of-use (carveable) | Nov. 21, 2044Active | Discovered |
| 12049503 | Method-of-use (carveable) | Jul. 25, 2044Active | Discovered |
| 11899017 | Other | Feb. 8, 2044Active | Discovered |
| 11767361 | Method-of-use (carveable) | Sep. 21, 2043Active | Discovered |
| 11585817 | Other | Feb. 16, 2043Active | Discovered |
| 11566073 | Method-of-use (carveable) | Jan. 26, 2043Active | Discovered |
| 11560430 | Formulation/compound | Jan. 19, 2043Active | Discovered |
| 11542312 | Method-of-use (carveable) | Dec. 29, 2042Active | Discovered |
| 11390663 | Other | Jul. 14, 2042Active | Discovered |
| 11332529 | Method-of-use (carveable) | May. 12, 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 658 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.