Influenza A (H5N1) Monovalent Vaccine, Adjuvanted (Audenz)
Influenza A (H5N1) Monovalent Vaccine, Adjuvanted is an FDA-licensed reference biologic from Seqirus 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
Audenz Influenza A (H5N1) Monovalent Vaccine, Adjuvanted
Seqirus Inc.
- Approved
- Jan 31, 2020
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Influenza A (H5N1) Monovalent Vaccine, Adjuvanted, in chronological order.
Reference approval
Approval date of the reference Influenza A (H5N1) Monovalent Vaccine, Adjuvanted product.
6 yr 5 mo ago
Frequently asked questions
Are there biosimilars approved for Influenza A (H5N1) Monovalent Vaccine, Adjuvanted (Audenz)?
No 351(k) biosimilars or interchangeable biosimilars referencing Influenza A (H5N1) Monovalent Vaccine, Adjuvanted are listed in the FDA Purple Book yet.
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