PEGUNIGALSIDASE ALFA-IWXJ | B761161 | CHIESI FARMACEUTICI SPA
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 (May. 9, 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) | May. 9, 2035 | 8y 9mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | May. 9, 2035 | 8y 9mo 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 11505790(composition)· AI-discovered, not Purple-Book-listed · relevance 90/100. This caps practical skinny-label entry; it does not move the licensure floor above.
3 formulation/compound (cap skinny entry) · 0 method-of-use (carveable — gate nothing) · 3 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 11505790 | Formulation/compound | Nov. 17, 2042Active | Discovered |
| 10221408 | Formulation/compound | Feb. 28, 2039Active | Discovered |
| 9557340 | Other | Jan. 26, 2037Active | Discovered |
| 9469683 | Formulation/compound | Oct. 13, 2036Active | Discovered |
| 9279007 | Other | Mar. 3, 2036Active | Discovered |
| 7851143 | Other | Dec. 9, 2030Active | 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.
6 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.