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FDA Purple Book · Reference family

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 Pasteur Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2020

Reference approved

Reference product

351(a)BLA 125701

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

Sanofi Pasteur Inc.

Approved
Apr 23, 2020
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

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

  1. First licensure

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

    6 yr 2 mo ago

  2. Reference approval

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

    6 yr 2 mo ago

  3. Reference exclusivity ends

    12-year reference-product exclusivity under the BPCIA.

    in 6 yr

Frequently asked questions

Are there biosimilars approved for Meningococcal (Groups A, C, Y, W) Conjugate Vaccine (Menquadfi)?

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

When does Meningococcal (Groups A, C, Y, W) Conjugate Vaccine (Menquadfi) lose reference-product exclusivity?

Meningococcal (Groups A, C, Y, W) Conjugate Vaccine's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending April 23, 2032.

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