Hepatitis A Vaccine (Havrix)
Hepatitis A 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
1995
Reference approved
Reference product
Havrix Hepatitis A Vaccine
GlaxoSmithKline Biologicals
- Approved
- Feb 22, 1995
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Hepatitis A Vaccine, in chronological order.
Reference approval
Approval date of the reference Hepatitis A Vaccine product.
31 yr 9 mo ago
Frequently asked questions
Are there biosimilars approved for Hepatitis A Vaccine (Havrix)?
No 351(k) biosimilars or interchangeable biosimilars referencing Hepatitis A Vaccine are listed in the FDA Purple Book yet.
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