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BLA

TIVIDENOFUSP ALFA-EKNM | B761485 | DENALI THERAPEUTICS INC.

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

March 24, 2038(4158 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Mar. 24, 2038	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 761485

351(a) ReferenceLicensedCDERFor Injection

Proper Name

tividenofusp alfa-eknm

Applicant

Denali Therapeutics Inc.

Approval Date

March 24, 2026

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 15, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 150MG/VIAL

▴

INJECTION;POWDER,FOR SOLUTION | Approved: 2026-03-24 00:00:00

No patent or exclusivity listings for this strength.