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Purple Book reference family · 351(a) biologic

nadofaragene firadenovec-vncg (Adstiladrin)

nadofaragene firadenovec-vncg is an FDA-licensed reference biologic from Ferring Pharmaceuticals A/S.

351(a) biologicBLA 125700 Ferring Pharmaceuticals A/S
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2022

Reference product

Originator biologic
351(a)BLA 125700

Adstiladrin nadofaragene firadenovec-vncg

Ferring Pharmaceuticals A/S

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

Exclusivity & patent cliffs

Protection horizon
  1. First licensure

    Date nadofaragene firadenovec-vncg was first licensed by the FDA.

    3 yr 10 mo ago

  2. Reference approval

    Approval date of the reference nadofaragene firadenovec-vncg product.

    3 yr 10 mo ago

  3. Reference exclusivity ends

    12-year reference-product exclusivity under the BPCIA.

    in 8 yr 4 mo

nadofaragene firadenovec-vncg: 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 nadofaragene firadenovec-vncg.

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