Purple Book reference family · 351(a) biologic
Influenza A (H5N1) Monovalent Vaccine, Adjuvanted (Audenz)
Influenza A (H5N1) Monovalent Vaccine, Adjuvanted is an FDA-licensed reference biologic from Seqirus Inc..
351(a) biologicBLA 125692 Seqirus Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2020
Reference product
Originator biologic
351(a)BLA 125692
Audenz Influenza A (H5N1) Monovalent Vaccine, Adjuvanted
Seqirus Inc.
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Influenza A (H5N1) Monovalent Vaccine, Adjuvanted product.
6 yr 7 mo ago
Influenza A (H5N1) Monovalent Vaccine, Adjuvanted: 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 A (H5N1) Monovalent Vaccine, Adjuvanted.
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