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Purple Book reference family · 351(a) biologic

mirikizumab-mrkz (Omvoh)

mirikizumab-mrkz is an FDA-licensed reference biologic from Eli Lilly and Company.

351(a) biologicBLA 761279 Eli Lilly and Company
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2025

Reference product

Originator biologic
351(a)BLA 761279

Omvoh mirikizumab-mrkz

Eli Lilly and Company

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

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

    Approval date of the reference mirikizumab-mrkz product.

    1 yr 7 mo ago

mirikizumab-mrkz: 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 mirikizumab-mrkz.

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Agent CTA Background

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