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Biotechnology: Pharmaceutical Preparations
LegalAug 11, 2026, 08:32 AM

Ultragenyx Settles DOJOLVI Patent Litigation with Esjay Pharma

AI Summary

Ultragenyx Pharmaceutical Inc. and Baylor Research Institute have reached a settlement agreement with Esjay Pharma Private Limited and Esjay Pharma LLC, resolving patent litigation related to the Company's DOJOLVI® (triheptanoin) oral liquid. The litigation stemmed from Esjay's submission of an Abbreviated New Drug Application seeking approval for a generic version of DOJOLVI. Under the terms, Ultragenyx will grant Esjay a non-exclusive, royalty-free license to market its generic DOJOLVI starting January 1, 2033, with a potential extension to July 1, 2033, if pediatric exclusivity is granted. Other similar patent litigations concerning DOJOLVI remain ongoing.

Key Highlights

  • Ultragenyx and Baylor Research Institute settled patent litigation with Esjay Pharma.
  • Litigation concerned Esjay's Abbreviated New Drug Application for generic DOJOLVI®.
  • Ultragenyx granted Esjay a non-exclusive, royalty-free license for generic DOJOLVI.
  • Generic DOJOLVI launch date set for January 1, 2033.
  • Launch date extends to July 1, 2033, if pediatric exclusivity is granted for DOJOLVI.
  • Similar patent litigation against other ANDA filers for DOJOLVI remains pending.