Purple Book product · Reference 351(a)
Hepcludex
bulevirtide-gmod
May 22, 2026
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
May 22, 2026
2 mo ago
Today
Pharmaceutical detail
Strength
8.5MG
Dosage form
For Injection
Route
Subcutaneous
Presentation
Single-Dose Vial
Center
CDER
License number
2258
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Source provenance
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v7Jul 02, 2026
- v6Jul 02, 2026
- v5Jul 02, 2026
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
- v1Jul 02, 2026
Frequently asked questions
Does Hepcludex have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Hepcludex are listed in the FDA Purple Book yet.
What is Hepcludex's BLA number?
Hepcludex is licensed under BLA 761468, held by Gilead Sciences, Inc..
When was Hepcludex approved by the FDA?
Hepcludex was approved by the FDA on May 22, 2026.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
