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FDA Purple Book · Reference family

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (Arepanrix)

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted is an FDA-licensed reference biologic from ID Biomedical Corporation of Quebec. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2013

Reference approved

Reference product

351(a)BLA 125419

Arepanrix Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

ID Biomedical Corporation of Quebec

Approved
Nov 22, 2013
Marketing
Disc
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, in chronological order.

  1. Reference approval

    Approval date of the reference Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted product.

    12 yr 8 mo ago

Frequently asked questions

Are there biosimilars approved for Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (Arepanrix)?

No 351(k) biosimilars or interchangeable biosimilars referencing Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted are listed in the FDA Purple Book yet.

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