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Purple Book reference family · 351(a) biologic

Influenza Virus Vaccine, H5N1

Influenza Virus Vaccine, H5N1 is an FDA-licensed reference biologic from Sanofi Vaccines US Inc..

351(a) biologicBLA 125244 Sanofi Vaccines US Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2007

Reference product

Originator biologic
351(a)BLA 125244

Not listed Influenza Virus Vaccine, H5N1

Sanofi Vaccines US Inc.

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

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

    Approval date of the reference Influenza Virus Vaccine, H5N1 product.

    19 yr 7 mo ago

Influenza Virus Vaccine, H5N1: 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 Influenza Virus Vaccine, H5N1.

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