Xeris sues generic drugmakers over Recorlev patents

Xeris Biopharma Holdings Inc. (NASDAQ: XERS) subsidiaries filed patent infringement lawsuits against Torrent Pharmaceuticals Limited and Somerset Therapeutics LLC in U.S. District Court for the District of New Jersey. The lawsuits target the companies' applications to produce generic versions of Recorlev, a treatment for endogenous Cushing's syndrome.

The legal action follows receipt of Paragraph IV Certification Notice Letters from both companies, which filed Abbreviated New Drug Applications with the Food and Drug Administration seeking approval for generic levoketoconazole products. The generic drugmakers alleged that four Orange Book-listed patents covering Recorlev are invalid, unenforceable, or will not be infringed by their proposed products.

Xeris seeks an injunction to prevent manufacture, use and sale of generic versions of Recorlev until the expiration of its patents in March 2040. The four patents in question are U.S. Patent Numbers 11,020,393, 11,278,547, 11,903,940, and 12,377,096.

"We are confident in the quality and strength of the intellectual property we have developed for Recorlev," said John P. Shannon, chief executive of Xeris Biopharma. "We have filed this patent infringement lawsuit to vigorously defend our position."

Recorlev also has orphan drug exclusivity through December 2028. Xeris indicated it may receive additional notice letters from other companies seeking to produce generic versions and intends to defend its intellectual property rights for the drug.

The company's subsidiaries, Xeris Pharmaceuticals Inc. and Strongbridge Dublin Limited, are represented by Latham & Watkins LLP in the litigation. The information is based on a company press release.

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