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Purple Book reference family · 351(a) biologic

Coagulation Factor VIIa (Recombinant) (Novoseven, Novoseven Rt)

Coagulation Factor VIIa (Recombinant) is an FDA-licensed reference biologic from Novo Nordisk Inc..

351(a) biologicBLA 103665 Novo Nordisk Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1999

Reference product

Originator biologic
351(a)BLA 103665

Novoseven, Novoseven Rt Coagulation Factor VIIa (Recombinant)

Novo Nordisk Inc.

View full reference-product record
Approved
Marketing
Disc
Center
CBER
Patents
None listed

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for Coagulation Factor VIIa (Recombinant) from the RCSB Protein Data Bank (PDB 1QFK).

3D molecular structure of Coagulation Factor VIIa (Recombinant) (PDB entry 1QFK)

Interactive biological assembly from PDB entry 1QFK. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here, with no need to leave the page.

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

    Approval date of the reference Coagulation Factor VIIa (Recombinant) product.

    27 yr 10 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    5 yr 3 mo ago

Coagulation Factor VIIa (Recombinant): 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 Coagulation Factor VIIa (Recombinant).

Related FDA reference tools

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