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FDA Purple Book · Reference family

Pneumococcal Vaccine, Polyvalent (Pneumovax 23)

Pneumococcal Vaccine, Polyvalent 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

1977

Reference approved

Reference product

351(a)BLA 101094

Pneumovax 23 Pneumococcal Vaccine, Polyvalent

Merck Sharp & Dohme LLC

Approved
Nov 21, 1977
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Pneumococcal Vaccine, Polyvalent, in chronological order.

  1. Reference approval

    Approval date of the reference Pneumococcal Vaccine, Polyvalent product.

    49 yr 3 mo ago

Frequently asked questions

Are there biosimilars approved for Pneumococcal Vaccine, Polyvalent (Pneumovax 23)?

No 351(k) biosimilars or interchangeable biosimilars referencing Pneumococcal Vaccine, Polyvalent are listed in the FDA Purple Book yet.

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