GALSULFASE | B125117 | BIOMARIN
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved May. 31, 2005 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | Open now | Open now | no live licensure floor |
| Full-label entry | May. 31, 2012 | Passed | no live block |
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 12280101(formulation)· AI-discovered, not Purple-Book-listed · relevance 72/100. This caps practical skinny-label entry; it does not move the licensure floor above.
13 formulation/compound (cap skinny entry) · 9 method-of-use (carveable — gate nothing) · 12 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12440525 | Method-of-use (carveable) | Oct. 9, 2045Active | Discovered |
| 12280101 | Formulation/compound | Apr. 17, 2045Active | Discovered |
| 12076353 | Method-of-use (carveable) | Aug. 29, 2044Active | Discovered |
| 11998643 | Formulation/compound | May. 30, 2044Active | Discovered |
| 11517598 | Method-of-use (carveable) | Dec. 1, 2042Active | Discovered |
| 11083741 | Method-of-use (carveable) | Aug. 5, 2041Active | Discovered |
| 10814008 | Other | Oct. 22, 2040Active | Discovered |
| 10660972 | Formulation/compound | May. 21, 2040Active | Discovered |
| 10300113 | Formulation/compound | May. 23, 2039Active | Discovered |
| 10100372 | Other | Oct. 11, 2038Active | Discovered |
| 10092540 | Method-of-use (carveable) | Oct. 4, 2038Active | Discovered |
| 9889203 | Other | Feb. 8, 2038Active | Discovered |
| 9873867 | Other | Jan. 18, 2038Active | Discovered |
| 9814762 | Formulation/compound | Nov. 9, 2037Active | Discovered |
| 9561246 | Method-of-use (carveable) | Feb. 2, 2037Active | Discovered |
Showing 15 of 34 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.
34 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.