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FDA Purple Book · Reference family

Smallpox and Mpox Vaccine, Live, Non-replicating (Jynneos)

Smallpox and Mpox Vaccine, Live, Non-replicating is an FDA-licensed reference biologic from Bavarian Nordic A/S. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2019

Reference approved

Reference product

351(a)BLA 125678

Jynneos Smallpox and Mpox Vaccine, Live, Non-replicating

Bavarian Nordic A/S

Approved
Sep 24, 2019
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Smallpox and Mpox Vaccine, Live, Non-replicating, in chronological order.

  1. Reference approval

    Approval date of the reference Smallpox and Mpox Vaccine, Live, Non-replicating product.

    6 yr 9 mo ago

Frequently asked questions

Are there biosimilars approved for Smallpox and Mpox Vaccine, Live, Non-replicating (Jynneos)?

No 351(k) biosimilars or interchangeable biosimilars referencing Smallpox and Mpox Vaccine, Live, Non-replicating are listed in the FDA Purple Book yet.

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