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Purple Book reference family · 351(a) biologic

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 Vaccines US Inc..

351(a) biologicBLA 125089 Sanofi Vaccines US Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2005

Reference product

Originator biologic
351(a)BLA 125089

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

Sanofi Vaccines US Inc.

View full reference-product record
Approved
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

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

    21 yr 10 mo ago

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

Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.

Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine.

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Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.