IDURSULFASE | B125151 | SHIRE
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Jul. 24, 2006 — 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 | Jul. 24, 2013 | 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 12178861(formulation)· AI-discovered, not Purple-Book-listed · relevance 68/100. This caps practical skinny-label entry; it does not move the licensure floor above.
25 formulation/compound (cap skinny entry) · 1 method-of-use (carveable — gate nothing) · 7 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12178861 | Formulation/compound | Dec. 26, 2044Active | Discovered |
| 11998643 | Formulation/compound | May. 30, 2044Active | Discovered |
| 11845935 | Formulation/compound | Dec. 14, 2043Active | Discovered |
| 11779635 | Formulation/compound | Oct. 5, 2043Active | Discovered |
| 11116823 | Formulation/compound | Sep. 9, 2041Active | Discovered |
| 11020459 | Formulation/compound | May. 27, 2041Active | Discovered |
| 11020461 | Method-of-use (carveable) | May. 27, 2041Active | Discovered |
| 10722559 | Formulation/compound | Jul. 23, 2040Active | Discovered |
| 10238720 | Formulation/compound | Mar. 21, 2039Active | Discovered |
| 10221400 | Other | Feb. 28, 2039Active | Discovered |
| 9937244 | Formulation/compound | Apr. 5, 2038Active | Discovered |
| 9932568 | Formulation/compound | Mar. 29, 2038Active | Discovered |
| 9809796 | Other | Nov. 2, 2037Active | Discovered |
| 9770410 | Formulation/compound | Sep. 21, 2037Active | Discovered |
| 9694057 | Formulation/compound | Jun. 29, 2037Active | Discovered |
Showing 15 of 33 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.
33 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.