Purple Book reference family · 351(a) biologic
collagenase (Santyl)
collagenase is an FDA-licensed reference biologic from Smith & Nephew, Inc..
351(a) biologicBLA 101995 Smith & Nephew, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1965
Reference product
Originator biologic
351(a)BLA 101995
Santyl collagenase
Smith & Nephew, Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference collagenase product.
62 yr ago
collagenase: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for collagenase.
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