Coagulation Factor VIIa (Recombinant) (Novoseven, Novoseven Rt)
Coagulation Factor VIIa (Recombinant) is an FDA-licensed reference biologic from Novo Nordisk Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1999
Reference approved
Reference product
Novoseven, Novoseven Rt Coagulation Factor VIIa (Recombinant)
Novo Nordisk Inc.
- Approved
- Mar 25, 1999
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Coagulation Factor VIIa (Recombinant), in chronological order.
Reference approval
Approval date of the reference Coagulation Factor VIIa (Recombinant) product.
27 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
5 yr ago
Frequently asked questions
Are there biosimilars approved for Coagulation Factor VIIa (Recombinant) (Novoseven, Novoseven Rt)?
No 351(k) biosimilars or interchangeable biosimilars referencing Coagulation Factor VIIa (Recombinant) are listed in the FDA Purple Book yet.
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