Skip to content
Assyro AI
Purple Book reference family · 351(a) biologic

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.

351(a) biologicBLA 125678 Bavarian Nordic A/S
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2019

Reference product

Originator biologic
351(a)BLA 125678

Jynneos Smallpox and Mpox Vaccine, Live, Non-replicating

Bavarian Nordic A/S

View full reference-product record
Approved
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

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

    6 yr 11 mo ago

Smallpox and Mpox Vaccine, Live, Non-replicating: 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 Smallpox and Mpox Vaccine, Live, Non-replicating.

Related FDA reference tools

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.