UroGen Pharma Ltd., a biotech company, announced that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Teva Pharmaceuticals USA, and Teva Pharmaceutical Industries, alleging infringement of U.S. Patent Numbers 9,040,074 and 9,950,069.

Both patents are listed in the U.S. Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) for JELMYTO (mitomycin) for pyelocalyceal solution.

JELMYTO is indicated for the treatment of adults with low-grade, upper tract urothelial cancer (LG-UTUC) and utilizes UroGen’s RTGel reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology.

“UroGen pioneered a significant breakthrough and remains at the forefront of transforming urothelial cancer treatment,” said Liz Barrett, President and CEO, UroGen. “UroGen has full confidence in the strength of its patents and plans to vigorously defend our intellectual property rights.”

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 ’074 and ’069 patents.