Legal Proceedings.
−Removed: On April 2, 2024, the Company filed a lawsuit in the U.S.
−Removed: District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S.
−Removed: Patent Numbers 9,040,074 and 9,950,069 and seeking a permanent injunction preventing U.S.
−Removed: market entry of Teva’s generic product prior to the expiry of such patents.
+Added: On April 2, 2024, we filed a lawsuit in the U.S.
+Added: District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc.
+Added: (together with Teva Pharmaceuticals, Inc., "Teva"), and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S.
+Added: Patent Numbers 9,040,074 and 9,950,069 in response to Teva’s submission of an Abbreviated New Drug Application (“ANDA”) to the FDA seeking approval to manufacture, use, or sell a generic version of Jelmyto in the United States prior to the expiration of such patents.
+Added: We sought a permanent injunction preventing U.S.
+Added: market entry of Teva’s generic product prior to the expiration of such patents.
By written stipulation dated June 11, 2024, Teva Pharmaceutical Industries, Ltd.
was dismissed from the action.
−Removed: On May 19, 2025 the Company filed an Amended Complaint, adding U.S.
−Removed: Patent 12,268,745 to the litigation (the “745 Patent”).
−Removed: Patent and Trademark Office issued the ‘745 Patent on April 8, 2025, and the Company subsequently added this patent to the Orange Book for JELMYTO.
−Removed: By orders dated February 27, 2025, and June 26, 2025, the court approved the parties’ joint stipulations to remove the Markman hearing and any related claim-construction proceedings from the court’s calendar.
−Removed: Following certain stipulations, the case is now styled as UroGen Pharma Ltd.
−Removed: Teva Pharmaceuticals, Inc.
−Removed: By order dated January 12, 2026, the court approved the parties’ joint stipulation to dismiss counts I, II, III, and IV of the Company’s Amended Complaint alleging infringement by Teva of U.S.
−Removed: Patent Numbers 9,040,074 and 9,950,069, with prejudice, and to dismiss counts I and II of Teva’s counterclaims seeking declaratory judgment that U.S.
−Removed: Patent Numbers 9,040,074 and 9,950,069 are invalid, as moot.
−Removed: By order dated April 27, 2026, the court approved the parties' joint stipulation to extend the deadlines for expert discovery and pre-trial activities and to postpone trial until January 2027, subject to the court's availability.
−Removed: No ANDA may be finally approved by the FDA until the expiration of Orphan Drug Exclusivity covering JELMYTO in April 2027.
−Removed: If the Company is unsuccessful in securing the requested court relief, JELMYTO may be subject to immediate competition from an FDA approved generic product after regulatory exclusivity for JELMYTO expires in April 2027.
+Added: On June 2, 2026, we entered into a settlement and license agreement (the “Agreement”) with Teva, resolving this litigation.
+Added: Under the Agreement, we have agreed to grant Teva a non-exclusive license to sell its generic version of Jelmyto beginning on September 15, 2030, if approved by the FDA, unless certain limited circumstances customarily included in these types of agreements occur.
+Added: On June 3, 2026, the court granted the parties’ Stipulated Dismissal Order, dismissing and closing the civil action.
+Added: As required by law, the parties submitted the Agreement to the U.S.
+Added: Federal Trade Commission and U.S.
+Added: Department of Justice for review.
From time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations.
−Removed: Other than as set forth above, we are not currently a party to any material legal proceedings.
+Added: We are not currently a party to any material legal proceedings.
Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
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.