← Back to RARE filing summaryThis is the extracted source text from the SEC filing. Formatting may differ from the original document.
Ultragenyx Pharmaceutical Inc. and Baylor Research Institute v. Navinta LLC, Aurobindo Pharma Limited, Aurobindo Pharma USA, Inc., Esjay Pharma Private Limited, and Esjay Pharma LLC
Ultragenyx Pharmaceutical Inc. and Baylor Research Institute v. Somerset Therapeutics LLC, Somerset Pharma LLC, Somerset Therapeutics Private Limited, and Odin Pharmaceuticals LLC
Ultragenyx Pharmaceutical Inc. and Baylor Research Institute v. Sun Pharmaceutical Industries Limited and Sun Pharmaceutical Industries, Inc.
In September 2024, we filed a patent infringement suit in the United States District Court for the District of New Jersey asserting U.S. Patent No. 8,697,748, or the ’748 patent, a 2029-expiring patent listed in the FDA’s Orange Book for Dojolvi® (triheptanoin), under the Hatch-Waxman Act against Navinta LLC, or Navinta; Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc., or collectively, Aurobindo; and Esjay Pharma LLC and Esjay Pharma Private Limited, or collectively, Esjay. The suit was filed in response to notices from Navinta, Aurobindo, and Esjay concerning their submission of Abbreviated New Drug Applications, or ANDAs, with the FDA, seeking FDA approval to market a generic version of Dojolvi® prior to the expiration of the ’748 patent.
In February 2026, we were granted U.S. Patent No. 12,551,461, or the ’461 patent. The ’461 patent was listed in the FDA’s Orange Book for Dojolvi® shortly after issuance. In April 2026, we filed an additional patent infringement suit asserting the ’461 patent against Navinta, Aurobindo, and Esjay. The ’461 patent is expected to expire in 2034.
In April 2026, we filed a patent infringement suit asserting the ’748 and ’461 patents under the Hatch-Waxman Act against Somerset Therapeutics LLC, Somerset Pharma LLC, Somerset Therapeutics Private Limited, and Odin Pharmaceuticals LLC, or collectively, Somerset, in the United States District Court for the District of New Jersey. The suit was filed in response to a notice from Somerset concerning its submission of an ANDA with the FDA, seeking FDA approval to market a generic version of Dojolvi® prior to the expiration of the ’748 and ’461 patents.
In April 2026, the United States District Court for the District of New Jersey consolidated the above-referenced suits against Navinta, Aurobindo, Esjay, and Somerset.
In July 2026, we filed a patent infringement suit asserting the ‘748 and ‘461 patents under the Hatch-Waxman Act against Sun Pharmaceutical Industries Limited and Sun Pharmaceutical Industries, Inc., or collectively Sun Pharma, in the United States District Court for the District of New Jersey. The suit was filed in response to a notice from Sun Pharma concerning the submission of an ANDA with the FDA, seeking FDA approval to market a generic version of Dojolvi® prior to the expiration of the ‘748 and ‘461 patents.
In addition to the ’748 and ’461 patents for Dojolvi listed in the Orange Book, Dojolvi is also protected in the U.S. by orphan drug exclusivity for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD) until June 30, 2027.
Ultragenyx Pharmaceutical Inc. v. Catalent Maryland, Inc. and Catalent Pharma Solutions LLC
In October 2024, we filed a suit against Catalent Maryland, Inc. and Catalent Pharma Solutions, LLC, or collectively, Catalent, in the Superior Court of the State of Delaware alleging that Catalent fraudulently mispresented its manufacturing capabilities and serially breached the terms of its manufacturing agreement with us. Our suit seeks monetary damages from Catalent in excess of $100 million.
In February 2025, we filed an amended complaint following Catalent’s response and Catalent subsequently moved to dismiss the amended complaint. In December 2025, the court denied Catalent’s motion to dismiss our fraud claim. In January 2026, Catalent answered our complaint and filed a counterclaim against us for breach of contract related to disputed invoices, seeking damages of approximately $8 million plus interest. Discovery is ongoing.
Stockholder Securities Litigation
Steven Bailey v. Ultragenyx Pharmaceutical Inc., Emil D. Kakkis, and Eric Crombez, M.D.
In February 2026, Steven Bailey filed a putative class action on behalf of certain of our stockholders against the Company, our CEO and our Chief Medical Officer in the United States District Court for the Northern District of California. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, or Exchange Act, alleging that the Company made false and misleading statements about the design and prospects of the UX143 Orbit and Cosmic clinical trials. The lawsuit seeks unspecified damages and other relief.
Derivative Litigation
35
In March 2026, a putative stockholder derivative complaint was filed in the United States District Court for the Northern District of California. The complaint named the members of our Board of Directors, our CEO and our Chief Medical Officer as defendants, and the Company as a nominal defendant. The complaint includes allegations of breaches of fiduciary duty, violations of Section 14(a) of the Exchange Act and gross mismanagement in connection with the UX143 Orbit and Cosmic clinical trials. The lawsuit seeks unspecified damages and other relief.
Except as disclosed above, we are not currently a party to any other material legal proceedings. We may, however, in the ordinary course of business face various claims brought by third parties or government regulators and, from time to time, make claims or take legal actions to assert our rights, including claims relating to our directors, officers, stockholders, intellectual property rights, employment matters and the safety or efficacy of our products. Any of these claims could subject us to costly litigation and, while we generally believe that we have adequate insurance to cover many different types of liabilities, our insurance carriers may deny coverage, may be inadequately capitalized to pay on valid claims, or our policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on our consolidated operations, cash flows and financial position. Additionally, any such claims, whether or not successful, could damage our reputation and business.