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 5 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.
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.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.