Purple Book reference family · 351(a) biologic
Hepatitis B Vaccine (Recombinant), Adjuvanted (Heplisav-B)
Hepatitis B Vaccine (Recombinant), Adjuvanted is an FDA-licensed reference biologic from Dynavax Technologies Corporation.
351(a) biologicBLA 125428 Dynavax Technologies Corporation
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2017
Reference product
Originator biologic
351(a)BLA 125428
Heplisav-B Hepatitis B Vaccine (Recombinant), Adjuvanted
Dynavax Technologies Corporation
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Hepatitis B Vaccine (Recombinant), Adjuvanted product.
8 yr 10 mo ago
Hepatitis B Vaccine (Recombinant), Adjuvanted: 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 Hepatitis B Vaccine (Recombinant), Adjuvanted.
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