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FDA Purple Book · Reference family

Zoster Vaccine Live (Zostavax)

Zoster Vaccine Live 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

2006

Reference approved

Reference product

351(a)BLA 125123

Zostavax Zoster Vaccine Live

Merck Sharp & Dohme LLC

Approved
May 25, 2006
Marketing
Disc
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Zoster Vaccine Live, in chronological order.

  1. Reference approval

    Approval date of the reference Zoster Vaccine Live product.

    20 yr 4 mo ago

Frequently asked questions

Are there biosimilars approved for Zoster Vaccine Live (Zostavax)?

No 351(k) biosimilars or interchangeable biosimilars referencing Zoster Vaccine Live are listed in the FDA Purple Book yet.

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