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: 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.
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.
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.