Ultragenyx Pharmaceutical Inc.: settles DOJOLVI patent suit

What happened On Oct 19, 2026, Ultragenyx Pharmaceutical Inc. and Baylor Research Institute entered into a settlement agreement with Navinta LLC resolving patent litigation related to the company’s DOJOLVI® (triheptanoin) oral liquid. The litigation was filed in the United States District Court for the District of New Jersey and arose from Navinta’s submission of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic version of DOJOLVI in the United States.

Key details

• Under the settlement, Ultragenyx will grant Navinta a non-exclusive, royalty-free license to market its generic version of DOJOLVI beginning Jan 1, 2033, which would be extended to Jul 1, 2033 if pediatric exclusivity is granted for DOJOLVI, subject to certain conditions and exceptions customary for agreements of this type.
• The settlement agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice as required by law.
• Similar patent litigation brought by Ultragenyx against other ANDA filers related to DOJOLVI remains pending in the U.S. District Court for the District of New Jersey.

Why it may matter Item reported: Item 8.01 (Other Events), covering a settlement agreement resolving patent litigation related to DOJOLVI. This filing does not show why the company acted or why any insider traded.