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FDA Purple Book · Reference family

Influenza Vaccine (Afluria, Afluria Quadrivalent)

Influenza Vaccine is an FDA-licensed reference biologic from Seqirus Pty Ltd.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2016

Reference approved

Reference product

351(a)BLA 125254

Afluria, Afluria Quadrivalent Influenza Vaccine

Seqirus Pty Ltd.

Approved
Aug 26, 2016
Marketing
Disc
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Influenza Vaccine, in chronological order.

  1. Reference approval

    Approval date of the reference Influenza Vaccine product.

    9 yr 11 mo ago

Frequently asked questions

Are there biosimilars approved for Influenza Vaccine (Afluria, Afluria Quadrivalent)?

No 351(k) biosimilars or interchangeable biosimilars referencing Influenza Vaccine are listed in the FDA Purple Book yet.

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