ALGLUCOSIDASE ALFA | B125291 | GENZYME
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. 24, 2010), 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. 24, 2022 | Passed | 12-year RPE floor (non-carveable) |
| Full-label entry | May. 24, 2022 | Passed | 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 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.
No patent or exclusivity listings for this strength.