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FDA Purple Book · Reference family

Respiratory Syncytial Virus Vaccine (Abrysvo)

Respiratory Syncytial Virus Vaccine is an FDA-licensed reference biologic from Pfizer Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2023

Reference approved

Reference product

351(a)BLA 125769

Abrysvo Respiratory Syncytial Virus Vaccine

Pfizer Inc.

Approved
May 31, 2023
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Respiratory Syncytial Virus Vaccine, in chronological order.

  1. Reference approval

    Approval date of the reference Respiratory Syncytial Virus Vaccine product.

    3 yr 1 mo ago

Frequently asked questions

Are there biosimilars approved for Respiratory Syncytial Virus Vaccine (Abrysvo)?

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

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