Legal Proceedings
+Added: On April 2, 2024, UroGen Pharma Ltd.
+Added: filed a lawsuit in the U.S.
+Added: 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.
+Added: Patent Numbers 9,040,074 and 9,950,069 and seeking a permanent injunction preventing market entry of a generic product from Teva prior to the expiry of such patents.
+Added: The Company stipulated to the dismissal of Teva Pharmaceutical Industries, Ltd.
+Added: without prejudice and the action continues against the other two Teva entities.
+Added: Both patents are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) for Jelmyto .
+Added: The lawsuit follows an Abbreviated New Drug Application filed by Teva Pharmaceuticals, Inc., which seeks authorization from the FDA to manufacture, use or sell a generic version of mitomycin for pyelocalyceal solution, 40 mg/vial in the United States before the expiry of the two patents referenced above.
+Added: By order dated February 27, 2025, the court approved the parties’ joint stipulation to remove the Markman hearing and any related claim-construction proceedings from the court’s calendar.
+Added: This matter is scheduled for a bench trial in October 2026.
From time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations.
−Removed: We are not currently a party to any legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business.
+Added: Other than as set forth above, 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.
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