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FDA Purple Book · Reference family

Hepatitis A Vaccine Inactivated (Vaqta)

Hepatitis A Vaccine Inactivated is an FDA-licensed reference biologic from Merck Sharp & Dohme LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

1996

Reference approved

Reference product

351(a)BLA 103606

Vaqta Hepatitis A Vaccine Inactivated

Merck Sharp & Dohme LLC

Approved
Mar 29, 1996
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Hepatitis A Vaccine Inactivated, in chronological order.

  1. Reference approval

    Approval date of the reference Hepatitis A Vaccine Inactivated product.

    30 yr 7 mo ago

Frequently asked questions

Are there biosimilars approved for Hepatitis A Vaccine Inactivated (Vaqta)?

No 351(k) biosimilars or interchangeable biosimilars referencing Hepatitis A Vaccine Inactivated are listed in the FDA Purple Book yet.

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