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Purple Book reference family · 351(a) biologic

Hepatitis A Vaccine Inactivated (Vaqta)

Hepatitis A Vaccine Inactivated is an FDA-licensed reference biologic from Merck Sharp & Dohme LLC.

351(a) biologicBLA 103606 Merck Sharp & Dohme LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1996

Reference product

Originator biologic
351(a)BLA 103606

Vaqta Hepatitis A Vaccine Inactivated

Merck Sharp & Dohme LLC

View full reference-product record
Approved
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

    Approval date of the reference Hepatitis A Vaccine Inactivated product.

    30 yr 9 mo ago

Hepatitis A Vaccine Inactivated: 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 Vaccine Inactivated.

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Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.