Hepatitis B Vaccine (Recombinant) (Engerix-B)
Hepatitis B Vaccine (Recombinant) is an FDA-licensed reference biologic from GlaxoSmithKline Biologicals. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1989
Reference approved
Reference product
Engerix-B Hepatitis B Vaccine (Recombinant)
GlaxoSmithKline Biologicals
- Approved
- Aug 28, 1989
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Hepatitis B Vaccine (Recombinant), in chronological order.
Reference approval
Approval date of the reference Hepatitis B Vaccine (Recombinant) product.
37 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for Hepatitis B Vaccine (Recombinant) (Engerix-B)?
No 351(k) biosimilars or interchangeable biosimilars referencing Hepatitis B Vaccine (Recombinant) are listed in the FDA Purple Book yet.
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