FDA Purple Book · Reference family
bulevirtide-gmod (Hepcludex)
bulevirtide-gmod is an FDA-licensed reference biologic from Gilead Sciences, 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
351(a)BLA 761468
Hepcludex bulevirtide-gmod
Gilead Sciences, Inc.
- Approved
- May 22, 2026
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for bulevirtide-gmod, in chronological order.
Reference approval
Approval date of the reference bulevirtide-gmod product.
2 mo ago
Frequently asked questions
Are there biosimilars approved for bulevirtide-gmod (Hepcludex)?
No 351(k) biosimilars or interchangeable biosimilars referencing bulevirtide-gmod are listed in the FDA Purple Book yet.
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- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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