PENPULIMAB-KCQX | B761258 | AKESO BIOPHARMA
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Apr. 23, 2025 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
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 11905322(composition)· AI-discovered, not Purple-Book-listed · relevance 90/100. This caps practical skinny-label entry; it does not move the licensure floor above.
2 formulation/compound (cap skinny entry) · 2 method-of-use (carveable — gate nothing) · 3 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12429485 | Other | Sep. 25, 2045Active | Discovered |
| 11905322 | Formulation/compound | Feb. 15, 2044Active | Discovered |
| 11858994 | Other | Dec. 28, 2043Active | Discovered |
| 11708612 | Other | Jul. 20, 2043Active | Discovered |
| 11685782 | Method-of-use (carveable) | Jun. 22, 2043Active | Discovered |
| 11014974 | Formulation/compound | May. 20, 2041Active | Discovered |
| 10918737 | Method-of-use (carveable) | Feb. 11, 2041Active | Discovered |
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.
7 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.