FDA Purple Book · Reference family
collagenase (Santyl)
collagenase is an FDA-licensed reference biologic from Smith & Nephew, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1965
Reference approved
Reference product
351(a)BLA 101995
Santyl collagenase
Smith & Nephew, Inc.
- Approved
- Jun 04, 1965
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for collagenase, in chronological order.
Reference approval
Approval date of the reference collagenase product.
61 yr 11 mo ago
Frequently asked questions
Are there biosimilars approved for collagenase (Santyl)?
No 351(k) biosimilars or interchangeable biosimilars referencing collagenase are listed in the FDA Purple Book yet.
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