COLLAGENASE | B101995 | SMITH AND NEPHEW
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Jun. 4, 1965 — 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 7727550(composition)· AI-discovered, not Purple-Book-listed · relevance 75/100. This caps practical skinny-label entry; it does not move the licensure floor above.
6 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 5 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 11946939 | Other | Mar. 28, 2044Active | Discovered |
| 11739311 | Other | Aug. 24, 2043Active | Discovered |
| 10415014 | Method-of-use (carveable) | Sep. 12, 2039Active | Discovered |
| 9987225 | Other | May. 31, 2038Active | Discovered |
| 9856454 | Method-of-use (carveable) | Dec. 28, 2037Active | Discovered |
| 8962666 | Method-of-use (carveable) | Feb. 19, 2035Active | Discovered |
| 8841125 | Other | Sep. 18, 2034Active | Discovered |
| 7727550 | Formulation/compound | May. 27, 2030Active | Discovered |
| 7592422 | Formulation/compound | Sep. 17, 2029Active | Discovered |
| 7432066 | Other | Oct. 2, 2028Active | Discovered |
| 7157556 | Formulation/compound | Dec. 28, 2026Active | Discovered |
| 6946264 | Formulation/compound | Sep. 15, 2025Expired | Discovered |
| 6849450 | Formulation/compound | Jan. 27, 2025Expired | Discovered |
| 6277558 | Formulation/compound | Aug. 16, 2021Expired | Discovered |
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.
14 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.