Hepatitis A & Hepatitis B (Recombinant) Vaccine (Twinrix)
Hepatitis A & Hepatitis B (Recombinant) Vaccine 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
2001
Reference approved
Reference product
Twinrix Hepatitis A & Hepatitis B (Recombinant) Vaccine
GlaxoSmithKline Biologicals
- Approved
- May 11, 2001
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Hepatitis A & Hepatitis B (Recombinant) Vaccine, in chronological order.
Reference approval
Approval date of the reference Hepatitis A & Hepatitis B (Recombinant) Vaccine product.
25 yr 5 mo ago
Frequently asked questions
Are there biosimilars approved for Hepatitis A & Hepatitis B (Recombinant) Vaccine (Twinrix)?
No 351(k) biosimilars or interchangeable biosimilars referencing Hepatitis A & Hepatitis B (Recombinant) Vaccine are listed in the FDA Purple Book yet.
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