FDA Purple Book · Reference family
reteplase (Retavase)
reteplase is an FDA-licensed reference biologic from Chiesi USA, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1996
Reference approved
Reference product
351(a)BLA 103786
Retavase reteplase
Chiesi USA, Inc.
- Approved
- Oct 30, 1996
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for reteplase, in chronological order.
Reference approval
Approval date of the reference reteplase product.
30 yr ago
Frequently asked questions
Are there biosimilars approved for reteplase (Retavase)?
No 351(k) biosimilars or interchangeable biosimilars referencing reteplase are listed in the FDA Purple Book yet.
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