Purple Book reference family · 351(a) biologic
reteplase (Retavase)
reteplase is an FDA-licensed reference biologic from Chiesi USA, Inc..
351(a) biologicBLA 103786 Chiesi USA, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1996
Reference product
Originator biologic
351(a)BLA 103786
Retavase reteplase
Chiesi USA, 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 reteplase product.
30 yr 2 mo ago
reteplase: 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 reteplase.
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