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Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra)

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine 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

2005

Reference approved

Reference product

351(a)BLA 125089

Menactra Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Sanofi Pasteur Inc.

Approved
Jan 14, 2005
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, in chronological order.

  1. Reference approval

    Approval date of the reference Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine product.

    21 yr 8 mo ago

Frequently asked questions

Are there biosimilars approved for Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra)?

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

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