Legal Proceedings.
−Removed: On April 2, 2024, UroGen Pharma Ltd.
−Removed: filed a lawsuit in the U.S.
+Added: On April 2, 2024, the Company filed a lawsuit in the U.S.
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 market entry of a generic product from Teva prior to the expiry of such patents.
−Removed: The Company stipulated to the dismissal of Teva Pharmaceutical Industries, Ltd.
−Removed: without prejudice and the action continues against the other two Teva entities.
−Removed: On May 19, 2025, the Company filed an amended complaint in this action, adding U.S.
−Removed: Patent Number 12,268,745 to this patent-infringement litigation.
−Removed: These patents are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) for Jelmyto .
−Removed: 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 patents referenced above.
−Removed: 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.
−Removed: Additionally, by the court’s order dated August 28, 2025, the parties stipulated that upon final approval of Teva’s ANDA, the commercial manufacture, use, sale, or offer for sale within the United States, or importation into the United States, of that product would infringe certain claims of the patents asserted in the action, thus narrowing the scope of the action to the validity of those certain patent claims.
−Removed: This matter is scheduled for a bench trial in October 2026.
+Added: Patent Numbers 9,040,074 and 9,950,069 and seeking a permanent injunction preventing U.S.
+Added: market entry of Teva’s generic product prior to the expiry of such patents.
+Added: By written stipulation dated June 11, 2024, Teva Pharmaceutical Industries, Ltd.
+Added: was dismissed from the action.
+Added: On May 19, 2025 the Company filed an Amended Complaint, adding U.S.
+Added: Patent 12,268,745 to the litigation (the “745 Patent”).
+Added: 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.
+Added: 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.
+Added: Following certain stipulations, the case is now styled as UroGen Pharma Ltd.
+Added: Teva Pharmaceuticals, Inc.
+Added: 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.
+Added: 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.
+Added: Patent Numbers 9,040,074 and 9,950,069 are invalid, as moot.
+Added: 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.
+Added: No ANDA may be finally approved by the FDA until the expiration of Orphan Drug Exclusivity covering JELMYTO in April 2027.
+Added: 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.
From time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations.
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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.