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HEPCLUDEX

BLA

BULEVIRTIDE-GMOD | B761468 | GILEAD SCIENCES INC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

May 22, 2038(4217 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	May. 22, 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 761468

351(a) ReferenceLicensedCDERFor Injection

Proper Name

bulevirtide-gmod

Applicant

Gilead Sciences, Inc.

Approval Date

May 22, 2026

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 26, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 8.5MG

▴

INJECTION;POWDER,FOR SOLUTION | Approved: 2026-05-22 00:00:00

No patent or exclusivity listings for this strength.