FDA Purple Book · Reference family
alteplase (Activase)
alteplase is an FDA-licensed reference biologic from Genentech, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1987
Reference approved
Reference product
351(a)BLA 103172
Activase alteplase
Genentech, Inc.
- Approved
- Nov 13, 1987
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for alteplase, in chronological order.
Reference approval
Approval date of the reference alteplase product.
39 yr 1 mo ago
Frequently asked questions
Are there biosimilars approved for alteplase (Activase)?
No 351(k) biosimilars or interchangeable biosimilars referencing alteplase are listed in the FDA Purple Book yet.
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