collagenase clostridium histolyticum (Xiaflex)
collagenase clostridium histolyticum is an FDA-licensed reference biologic from Auxilium Pharmaceuticals, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2010
Reference approved
Reference product
Xiaflex collagenase clostridium histolyticum
Auxilium Pharmaceuticals, Inc.
- Approved
- Feb 02, 2010
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for collagenase clostridium histolyticum, in chronological order.
Reference approval
Approval date of the reference collagenase clostridium histolyticum product.
16 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
5 yr 7 mo ago
Frequently asked questions
Are there biosimilars approved for collagenase clostridium histolyticum (Xiaflex)?
No 351(k) biosimilars or interchangeable biosimilars referencing collagenase clostridium histolyticum are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.