Purple Book reference family · 351(a) biologic
bulevirtide-gmod (Hepcludex)
bulevirtide-gmod is an FDA-licensed reference biologic from Gilead Sciences, Inc..
351(a) biologicBLA 761468 Gilead Sciences, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2026
Reference product
Originator biologic
351(a)BLA 761468
Hepcludex bulevirtide-gmod
Gilead Sciences, Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference bulevirtide-gmod product.
3 mo ago
bulevirtide-gmod: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for bulevirtide-gmod.
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