Purple Book reference family · 351(a) biologic
urokinase (Kinlytic)
urokinase is an FDA-licensed reference biologic from Microbix Biosystems Inc..
351(a) biologicBLA 021846 Microbix Biosystems Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1978
Reference product
Originator biologic
351(a)BLA 021846
Kinlytic urokinase
Microbix Biosystems Inc.
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference urokinase product.
49 yr 3 mo ago
urokinase: 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 urokinase.
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