ALGLUCOSIDASE ALFA | B125291 | GENZYME
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved May. 24, 2010 — 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 12414985(composition)· AI-discovered, not Purple-Book-listed · relevance 88/100. This caps practical skinny-label entry; it does not move the licensure floor above.
19 formulation/compound (cap skinny entry) · 22 method-of-use (carveable — gate nothing) · 9 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12414985 | Formulation/compound | Sep. 11, 2045Active | Discovered |
| 12305187 | Formulation/compound | May. 15, 2045Active | Discovered |
| 12290549 | Method-of-use (carveable) | May. 1, 2045Active | Discovered |
| 12251430 | Formulation/compound | Mar. 13, 2045Active | Discovered |
| 12246062 | Formulation/compound | Mar. 6, 2045Active | Discovered |
| 12213979 | Method-of-use (carveable) | Jan. 30, 2045Active | Discovered |
| 12208144 | Method-of-use (carveable) | Jan. 23, 2045Active | Discovered |
| 12139709 | Formulation/compound | Nov. 7, 2044Active | Discovered |
| 11998643 | Formulation/compound | May. 30, 2044Active | Discovered |
| 11970722 | Formulation/compound | Apr. 25, 2044Active | Discovered |
| 11944628 | Method-of-use (carveable) | Mar. 28, 2044Active | Discovered |
| 11859186 | Method-of-use (carveable) | Dec. 28, 2043Active | Discovered |
| 11753632 | Formulation/compound | Sep. 7, 2043Active | Discovered |
| 11712463 | Method-of-use (carveable) | Jul. 27, 2043Active | Discovered |
| 11672802 | Method-of-use (carveable) | Jun. 8, 2043Active | 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 99 AI-discovered patents by relevance.
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Stira Pharmaceuticals LLC FDA-2026-P-9043 · 5 docket documents Stira Pharmaceuticals LLC filed a citizen petition requesting that the FDA take specific regulatory action regarding drug development and approval processes. The petition seeks FDA guidance or policy clarification on matters related to pharmaceutical development, though the specific drug product nam | Other | 2026-08-11 | Open | Stira Pharmaceuticals LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.