POZELIMAB-BBFG | B761339 | REGENERON PHARMACEUTICALS
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 (Aug. 18, 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) | Aug. 18, 2035 | 9y 1mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Aug. 18, 2035 | 9y 1mo 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 12331109(composition)· AI-discovered, not Purple-Book-listed · relevance 78/100. This caps practical skinny-label entry; it does not move the licensure floor above.
31 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 16 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12404505 | Other | Aug. 28, 2045Active | Discovered |
| 12331109 | Formulation/compound | Jun. 12, 2045Active | Discovered |
| 12264343 | Method-of-use (carveable) | Mar. 27, 2045Active | Discovered |
| 12207628 | Formulation/compound | Jan. 23, 2045Active | Discovered |
| 12169203 | Other | Dec. 12, 2044Active | Discovered |
| 12157758 | Formulation/compound | Nov. 28, 2044Active | Discovered |
| 12152067 | Formulation/compound | Nov. 21, 2044Active | Discovered |
| 12089575 | Formulation/compound | Sep. 12, 2044Active | Discovered |
| 12066246 | Other | Aug. 15, 2044Active | Discovered |
| 11952430 | Formulation/compound | Apr. 4, 2044Active | Discovered |
| 11820815 | Formulation/compound | Nov. 16, 2043Active | Discovered |
| 11821001 | Other | Nov. 16, 2043Active | Discovered |
| 11633501 | Formulation/compound | Apr. 20, 2043Active | Discovered |
| 11530255 | Formulation/compound | Dec. 15, 2042Active | Discovered |
| 11407822 | Formulation/compound | Aug. 4, 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 337 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.