Ultragenyx settles DOJOLVI patent suit with Navinta over generic ANDA
The settlement, signed October 19, 2026, lets Navinta sell a generic triheptanoin product starting in 2033, with other ANDA litigation still ongoing.
Ultragenyx Pharmaceutical Inc. disclosed in an October 19, 2026 Form 8-K that it and Baylor Research Institute had reached a settlement agreement with Navinta LLC resolving patent litigation related to patents covering the company's DOJOLVI (triheptanoin) oral liquid.1
The dispute originated after Navinta filed an Abbreviated New Drug Application with the FDA seeking approval to market a generic version of DOJOLVI, prompting litigation in the U.S. District Court for the District of New Jersey.1
Under the deal, Ultragenyx agreed to let Navinta sell its generic version of DOJOLVI without paying royalties starting on January 1, 2033. That date could move to July 1, 2033 if DOJOLVI is granted pediatric exclusivity, and the license comes with conditions and exceptions the company described as standard for this type of settlement.1
Ultragenyx noted that its patent fight is not over. The company said similar litigation against other ANDA filers over DOJOLVI remains active in the same New Jersey federal court.1
As with other pharmaceutical patent settlements, this one is subject to antitrust review. The company said the settlement agreement will be submitted to the Federal Trade Commission and the Department of Justice as required by law.1 Ultragenyx also noted that its summary of the agreement in the filing does not purport to be a complete description of its terms.1
The filing was signed by Howard Horn, Ultragenyx's Executive Vice President, Chief Financial Officer, and Corporate Strategy, on October 19, 2026.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.