Ultragenyx Pharmaceutical Inc.

08/11/2026 | Press release | Distributed by Public on 08/11/2026 06:30

Material Event (Form 8-K)

Item 8.01

Other Events.

On August 7, 2026, Ultragenyx Pharmaceutical Inc. (the "Company") and Baylor Research Institute ("BRI") entered into a settlement agreement with Esjay Pharma Private Limited and Esjay Pharma LLC (collectively, "Esjay") resolving patent litigation related to the Company's DOJOLVIĀ® (triheptanoin) oral liquid. The litigation, which was filed in the United States District Court for the District of New Jersey, resulted from submission by Esjay of an Abbreviated New Drug Application ("ANDA") to the U.S. Food and Drug Administration seeking approval to market a generic version of DOJOLVI in the United States. Under the terms of the settlement agreement, the Company will grant Esjay a non-exclusive, royalty-free license to market its generic version of DOJOLVI beginning January 1, 2033, which would be extended to July 1, 2033 if pediatric exclusivity is granted for DOJOLVI, subject to certain conditions and exceptions customary for agreements of this type. Similar patent litigation brought by the Company against other ANDA filers related to DOJOLVI remains pending in the U.S. District Court for the District of New Jersey.

As required by law, the settlement agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice. The description of the settlement agreement contained herein does not purport to be complete.


Ultragenyx Pharmaceutical Inc. published this content on August 11, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on August 11, 2026 at 12:31 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]