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FDA Purple Book · Reference family

Meningococcal Groups A, B, C, W and Y Vaccine (PENMENVY)

Meningococcal Groups A, B, C, W and Y 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

2025

Reference approved

Reference product

351(a)BLA 125819

PENMENVY Meningococcal Groups A, B, C, W and Y Vaccine

GlaxoSmithKline Biologicals

Approved
Feb 14, 2025
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Meningococcal Groups A, B, C, W and Y Vaccine, in chronological order.

  1. Reference approval

    Approval date of the reference Meningococcal Groups A, B, C, W and Y Vaccine product.

    1 yr 4 mo ago

Frequently asked questions

Are there biosimilars approved for Meningococcal Groups A, B, C, W and Y Vaccine (PENMENVY)?

No 351(k) biosimilars or interchangeable biosimilars referencing Meningococcal Groups A, B, C, W and Y Vaccine are listed in the FDA Purple Book yet.

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