BELATACEPT | B125288 | 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 (Jun. 15, 2011), 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) | Jun. 15, 2023 | Passed | 12-year RPE floor (non-carveable) |
| Full-label entry | Jun. 15, 2023 | Passed | 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 12419953(composition)· AI-discovered, not Purple-Book-listed · relevance 75/100. This caps practical skinny-label entry; it does not move the licensure floor above.
34 formulation/compound (cap skinny entry) · 9 method-of-use (carveable — gate nothing) · 7 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12441780 | Method-of-use (carveable) | Oct. 9, 2045Active | Discovered |
| 12419953 | Formulation/compound | Sep. 18, 2045Active | Discovered |
| 12234483 | Other | Feb. 20, 2045Active | Discovered |
| 12030923 | Formulation/compound | Jul. 4, 2044Active | Discovered |
| 12012452 | Formulation/compound | Jun. 13, 2044Active | Discovered |
| 11939367 | Formulation/compound | Mar. 21, 2044Active | Discovered |
| 11708412 | Method-of-use (carveable) | Jul. 20, 2043Active | Discovered |
| 11385228 | Method-of-use (carveable) | Jul. 7, 2042Active | Discovered |
| 11261233 | Formulation/compound | Feb. 24, 2042Active | Discovered |
| 11203630 | Formulation/compound | Dec. 16, 2041Active | Discovered |
| 10961297 | Formulation/compound | Mar. 25, 2041Active | Discovered |
| 10808021 | Formulation/compound | Oct. 15, 2040Active | Discovered |
| 10590183 | Formulation/compound | Mar. 12, 2040Active | Discovered |
| 10570204 | Method-of-use (carveable) | Feb. 20, 2040Active | Discovered |
| 10538555 | Formulation/compound | Jan. 16, 2040Active | 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 78 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.