Purple Book reference family · 351(a) biologic
alteplase (Activase)
alteplase is an FDA-licensed reference biologic from Genentech, Inc..
351(a) biologicBLA 103172 Genentech, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1987
Reference product
Originator biologic
351(a)BLA 103172
Activase alteplase
Genentech, 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 alteplase product.
39 yr 3 mo ago
alteplase: 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 alteplase.
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