COLLAGENASE CLOSTRIDIUM HISTOLYTICUM | B125338 | AUXILIUM PHARMS
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Feb. 2, 2010 — 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 | Dec. 6, 2020 | Passed | no live block |
Best-skinny equals full-label — no carveable orphan block runs past the licensure floor.
Marketing-entry ceiling (litigation risk)
No listed or discovered patents.
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.
No patent or exclusivity listings for this strength.