Four Orange Book Listed Patents through March 2040
Orphan Drug Exclusivity through December 2028
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, announced that its subsidiaries, Xeris Pharmaceuticals, Inc. and Strongbridge Dublin Limited, have filed a patent infringement lawsuit under the Hatch-Waxman Act related to Recorlev® (levoketoconazole) in the United States District Court for the District of New Jersey against Torrent Pharmaceuticals Limited (along with its affiliate) and Somerset Therapeutics, LLC (along with its affiliates), each of which filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (the “FDA”) seeking approval to manufacture, use or sell a generic version of Recorlev® (levoketoconazole) (each, an “ANDA Filer”). Xeris’s complaint seeks an injunction to prevent the manufacture, use, and sale of a generic version of RECORLEV by each ANDA Filer until the expiration of Xeris’s patents in March 2040.
“We are confident in the quality and strength of the intellectual property we have developed for Recorlev,” said John P. Shannon, CEO of Xeris Biopharma. “We have filed this patent infringement lawsuit to vigorously defend our position.”
The complaint was filed following receipt of Paragraph IV Certification Notice Letters from the ANDA Filers (each a “Notice Letter”). In its respective Notice Letter, each ANDA Filer alleged that the four patents covering Recorlev that are listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book), scheduled to expire in March 2040 (U.S. Patent Numbers 11,020,393, 11,278,547, 11,903,940, and 12,377,096), are invalid, unenforceable, or will not be infringed by the respective ANDA Filer’s commercial manufacture, use, or sale of the generic levoketoconazole product described in its ANDA submission.
Xeris may receive additional Notice Letters in the future from ANDA filers seeking approval of a generic version of Recorlev and intends to enforce and defend its intellectual property rights relating to Recorlev. Xeris Pharmaceuticals, Inc. and Strongbridge Dublin Limited are represented in this litigation by Latham & Watkins, LLP.
