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FDA Purple Book · Reference family

Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined (Menomune)

Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined is an FDA-licensed reference biologic from Sanofi Pasteur Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

1999

Reference approved

Reference product

351(a)BLA 103926

Menomune Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined

Sanofi Pasteur Inc.

Approved
Dec 09, 1999
Marketing
Disc
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined, in chronological order.

  1. Reference approval

    Approval date of the reference Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined product.

    26 yr 10 mo ago

Frequently asked questions

Are there biosimilars approved for Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined (Menomune)?

No 351(k) biosimilars or interchangeable biosimilars referencing Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined are listed in the FDA Purple Book yet.

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