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Purple Book reference family · 351(a) biologic

Meningococcal (Groups A, C, Y, W) Conjugate Vaccine (Menquadfi)

Meningococcal (Groups A, C, Y, W) Conjugate Vaccine is an FDA-licensed reference biologic from Sanofi Vaccines US Inc..

351(a) biologicBLA 125701 Sanofi Vaccines US Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2020

Reference product

Originator biologic
351(a)BLA 125701

Menquadfi Meningococcal (Groups A, C, Y, W) 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. First licensure

    Date Meningococcal (Groups A, C, Y, W) Conjugate Vaccine was first licensed by the FDA.

    6 yr 6 mo ago

  2. Reference approval

    Approval date of the reference Meningococcal (Groups A, C, Y, W) Conjugate Vaccine product.

    6 yr 6 mo ago

  3. Reference exclusivity ends

    12-year reference-product exclusivity under the BPCIA.

    in 5 yr 8 mo

Meningococcal (Groups A, C, Y, W) 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, W) Conjugate Vaccine.

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Agent CTA Background

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