Ultragenyx Pharmaceutical Inc. has announced a significant settlement agreement with Navinta LLC concerning patent litigation related to its product, DOJOLVI (triheptanoin) oral liquid. The agreement, filed on October 19, 2026, resolves ongoing litigation that arose after Navinta submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) to market a generic version of DOJOLVI.
This settlement allows Navinta to market its generic version of DOJOLVI starting January 1, 2033. If pediatric exclusivity is granted for DOJOLVI, this date could be extended to July 1, 2033. The settlement includes customary conditions and exceptions typical for agreements of this nature.
Ultragenyx's decision to settle with Navinta comes amid a backdrop of ongoing patent litigations against other ANDA filers concerning DOJOLVI, which remain active in the U.S. District Court for the District of New Jersey. The company is likely aiming to streamline its legal challenges while still protecting its market position.
As required by law, the settlement agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. The details of the settlement are not exhaustive and represent a strategic move by Ultragenyx to navigate the complex landscape of pharmaceutical patents.
Ultragenyx Pharmaceutical Inc. is a prominent player in the pharmaceutical preparations industry, focusing on innovative therapies for rare diseases. The company is publicly traded on the Nasdaq under the ticker symbol RARE.
Looking ahead, the company may provide further updates on its ongoing litigation efforts and product developments as it continues to navigate the competitive landscape of the pharmaceutical industry.