Ultragenyx Pharmaceutical Inc. filed an 8-K on August 11, 2026, disclosing that it and Baylor Research Institute reached a settlement agreement on August 7, 2026, with Esjay Pharma Private Limited and Esjay Pharma LLC resolving patent litigation over a proposed generic version of DOJOLVI (triheptanoin) oral liquid.

Key Highlights

  • Settlement date: The agreement was entered into on August 7, 2026, between Ultragenyx, Baylor Research Institute, and Esjay Pharma Private Limited and Esjay Pharma LLC.
  • Product at issue: The litigation concerned DOJOLVI (triheptanoin) oral liquid, following Esjay's submission of an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version in the United States.
  • License start date: Under the settlement, Ultragenyx will grant Esjay a non-exclusive, royalty-free license to market its generic version of DOJOLVI beginning January 1, 2033.
  • Pediatric exclusivity extension: The license start date would be extended to July 1, 2033 if pediatric exclusivity is granted for DOJOLVI, subject to certain conditions and exceptions.
  • Other litigation pending: Similar patent litigation against other ANDA filers related to DOJOLVI remains pending in the U.S. District Court for the District of New Jersey.
  • Regulatory submission: The settlement agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice, as required by law.

Ultragenyx and BRI Resolve DOJOLVI ANDA Patent Litigation with Esjay Pharma

According to the filing, Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) and Baylor Research Institute entered into a settlement agreement with Esjay Pharma Private Limited and Esjay Pharma LLC on August 7, 2026. The dispute originated from Esjay's submission of an ANDA to the U.S. Food and Drug Administration seeking approval to market a generic version of DOJOLVI (triheptanoin) oral liquid in the United States. The patent litigation had been filed in the United States District Court for the District of New Jersey.

Under the terms of the settlement, the company disclosed it will grant Esjay a non-exclusive, royalty-free license to market its generic version of DOJOLVI starting January 1, 2033. The filing notes that this date 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." The filing does not specify financial terms or any monetary exchange between the parties.

The company also noted that similar patent litigation it brought 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 8-K was signed by Howard Horn, Executive Vice President, Chief Financial Officer, Corporate Strategy, and filed on August 11, 2026.

What Was Disclosed

Ultragenyx disclosed the settlement of ANDA-related patent litigation over DOJOLVI with Esjay Pharma, granting a non-exclusive, royalty-free generic license beginning no earlier than January 1, 2033, while noting that separate litigation against other ANDA filers remains ongoing.