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Purple Book reference family · 351(a) biologic

tividenofusp alfa-eknm (Avlayah)

tividenofusp alfa-eknm is an FDA-licensed reference biologic from Denali Therapeutics Inc..

351(a) biologicBLA 761485 Denali Therapeutics Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2026

Reference product

Originator biologic
351(a)BLA 761485

Avlayah tividenofusp alfa-eknm

Denali Therapeutics Inc.

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

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

    Approval date of the reference tividenofusp alfa-eknm product.

    4 mo ago

tividenofusp alfa-eknm: 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 tividenofusp alfa-eknm.

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