Purple Book reference family · 351(a) biologic
Hepatitis A & Hepatitis B (Recombinant) Vaccine (Twinrix)
Hepatitis A & Hepatitis B (Recombinant) Vaccine is an FDA-licensed reference biologic from GlaxoSmithKline Biologicals.
351(a) biologicBLA 103850 GlaxoSmithKline Biologicals
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2001
Reference product
Originator biologic
351(a)BLA 103850
Twinrix Hepatitis A & Hepatitis B (Recombinant) Vaccine
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 A & Hepatitis B (Recombinant) Vaccine product.
25 yr 7 mo ago
Hepatitis A & Hepatitis B (Recombinant) Vaccine: 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 A & Hepatitis B (Recombinant) Vaccine.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
