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Navinta LLC, Aurobindo Pharma Limited, Aurobindo Pharma USA, Inc., Esjay Pharma Private Limited and Esjay Pharma LLC
−Removed: On September 26, 2024, we filed a patent infringement suit under the Hatch-Waxman Act against Navinta, Aurobindo and Esjay in the United States District Court for the District of New Jersey.
−Removed: The suit is in response to notices from Navinta, Aurobindo, and Esjay concerning the filing of ANDAs with the FDA, seeking FDA approval to market a generic version of Dojolvi® (triheptanoin) along with Paragraph IV certifications which allege that one Orange Book-listed patent covering Dojolvi is invalid, unenforceable, and/or will not be infringed by the manufacture, use, or sale of the proposed generic product.
+Added: In September 2024, we filed a patent infringement suit under the Hatch-Waxman Act against Navinta LLC, or Navinta, Aurobindo Pharma Limited, or Aurobindo, and Esjay Pharma LLC, or Esjay, in the United States District Court for the District of New Jersey.
+Added: The suit is in response to notices from Navinta, Aurobindo, and Esjay concerning the filing of Abbreviated New Drug Applications, or ANDAs, with the FDA, seeking FDA approval to market a generic version of Dojolvi® (triheptanoin).
The filing of the suit triggers a stay preventing the FDA from granting the ANDAs final approval, which stay extends to December 30, 2027 (i.e., the date that is seven and one-half years from the June 30, 2020 approval of Dojolvi).
We intend to vigorously defend our intellectual property.
−Removed: In addition to the issued patents for Dojolvi listed in the Orange Book, we own a pending patent application relating to certain pharmaceutical compositions of triheptanoin, including Dojolvi, that would be expected to expire in 2034 upon an issuance.
+Added: In addition to the issued patents for Dojolvi listed in the Orange Book, in February 2026, a patent relating to certain pharmaceutical compositions of triheptanoin, including Dojolvi, issued in the United States and is expected to expire in 2034.
+Added: We expect to list this patent in the Orange Book shortly.
Dojolvi is also protected in the U.S.
−Removed: by regulatory exclusivity until 2025 and orphan drug exclusivity for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD) until 2027.
−Removed: Aurobindo and Navinta answered the complaint on December 2, 2024 and December 30, 2024, respectively.
−Removed: Esjay filed a motion to dismiss the suit on December 2, 2024.
−Removed: We filed an opposition to Esjay’s motion to dismiss on January 7, 2025.
+Added: by orphan drug exclusivity for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD) until 2027.
+Added: In December 2024, Esjay filed a motion to dismiss the suit and in April 2025, Navinta filed a motion for judgment on the pleadings, which we opposed in May 2025.
+Added: Discovery is ongoing.
Ultragenyx Pharmaceutical Inc.
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and Catalent Pharma Solutions LLC
−Removed: On October 9, 2024, we filed a suit against Catalent Maryland, Inc.
+Added: In October 2024, we filed a suit against Catalent Maryland, Inc.
and Catalent Pharma Solutions, LLC (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.
−Removed: Catalent filed its response, which included a motion to dismiss the fraud claim alleged in the suit, on December 18, 2024.
−Removed: We filed an amended complaint in reply to Catalent’s response on February 3, 2025.
+Added: In February 2025, we filed an amended complaint following Catalent’s response and Catalent subsequently moved to dismiss the amended complaint.
+Added: In December 2025, the court denied Catalent’s motion to dismiss our fraud claim.
+Added: 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.
+Added: Steven Bailey v.
+Added: Ultragenyx Pharmaceutical Inc., Emil D.
+Added: Kakkis, and Eric Crombez, M.D.
+Added: 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.
+Added: The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, alleging that the Company made false and misleading statements about the design and prospects of the UX143 Orbit and Cosmic clinical trials.
+Added: The lawsuit seeks unspecified damages and other relief.
Except as disclosed above, we are not currently a party to any other material legal proceedings.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.