Purple Book reference family · 351(a) biologic
tenecteplase (TNKase)
tenecteplase is an FDA-licensed reference biologic from Genentech, Inc..
351(a) biologicBLA 103909 Genentech, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2025
Reference product
Originator biologic
351(a)BLA 103909
TNKase tenecteplase
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 tenecteplase product.
1 yr 5 mo ago
tenecteplase: 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 tenecteplase.
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