Purple Book reference family · 351(a) biologic
Hepatitis B Vaccine (Recombinant) (Engerix-B)
Hepatitis B Vaccine (Recombinant) is an FDA-licensed reference biologic from GlaxoSmithKline Biologicals.
351(a) biologicBLA 103239 GlaxoSmithKline Biologicals
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1989
Reference product
Originator biologic
351(a)BLA 103239
Engerix-B Hepatitis B Vaccine (Recombinant)
GlaxoSmithKline Biologicals
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) product.
37 yr 7 mo ago
Hepatitis B Vaccine (Recombinant): 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).
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