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Purple Book reference family · 351(a) biologic

cenegermin-bkbj (Oxervate)

cenegermin-bkbj is an FDA-licensed reference biologic from Domp farmaceutici S.p.A..

351(a) biologicBLA 761094 Domp farmaceutici S.p.A.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2018

Reference product

Originator biologic
351(a)BLA 761094

Oxervate cenegermin-bkbj

Domp farmaceutici S.p.A.

View full reference-product record
Approved
Marketing
Rx
Center
CDER
Patents
None listed

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for cenegermin-bkbj from the RCSB Protein Data Bank (PDB 6YW8).

3D molecular structure of cenegermin-bkbj (PDB entry 6YW8)

Interactive biological assembly from PDB entry 6YW8. 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 cenegermin-bkbj product.

    8 yr 2 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    1 yr 1 mo ago

cenegermin-bkbj: 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 cenegermin-bkbj.

Related FDA reference tools

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