CIPAGLUCOSIDASE ALFA-ATGA | B761204 | AMICUS THERAP US
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Sep. 28, 2023 — 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 11208644(composition)· AI-discovered, not Purple-Book-listed · relevance 65/100. This caps practical skinny-label entry; it does not move the licensure floor above.
5 formulation/compound (cap skinny entry) · 0 method-of-use (carveable — gate nothing) · 19 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12203103 | Other | Jan. 16, 2045Active | Discovered |
| 11912741 | Other | Feb. 22, 2044Active | Discovered |
| 11912739 | Other | Feb. 22, 2044Active | Discovered |
| 11884703 | Other | Jan. 25, 2044Active | Discovered |
| 11839861 | Other | Dec. 7, 2043Active | Discovered |
| 11685943 | Other | Jun. 22, 2043Active | Discovered |
| 11635363 | Other | Apr. 20, 2043Active | Discovered |
| 11384342 | Other | Jul. 7, 2042Active | Discovered |
| 11369703 | Other | Jun. 23, 2042Active | Discovered |
| 11306341 | Other | Apr. 14, 2042Active | Discovered |
| 11208644 | Formulation/compound | Dec. 23, 2041Active | Discovered |
| 11160874 | Formulation/compound | Oct. 28, 2041Active | Discovered |
| 11060058 | Other | Jul. 8, 2041Active | Discovered |
| 10968252 | Other | Apr. 1, 2041Active | Discovered |
| 10421949 | Other | Sep. 19, 2039Active | Discovered |
Showing 15 of 24 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.
24 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.