tividenofusp alfa-eknm (Avlayah)
tividenofusp alfa-eknm is an FDA-licensed reference biologic from Denali Therapeutics Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2026
Reference approved
Reference product
Avlayah tividenofusp alfa-eknm
Denali Therapeutics Inc.
- Approved
- Mar 24, 2026
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for tividenofusp alfa-eknm, in chronological order.
Reference approval
Approval date of the reference tividenofusp alfa-eknm product.
2 mo ago
Frequently asked questions
Are there biosimilars approved for tividenofusp alfa-eknm (Avlayah)?
No 351(k) biosimilars or interchangeable biosimilars referencing tividenofusp alfa-eknm are listed in the FDA Purple Book yet.
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