Xeris Biopharma Holdings, Inc.
For the period ended Dec 31, 2025. Filed Mar 2, 2026.
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FY2025 · Filed Mar 2, 2026
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Item 3. Legal Proceedings
We received Paragraph IV certification notice letters (each, a “Notice Letter”) from three pharmaceutical companies (each, an “ANDA Filer”), providing notification to us that each ANDA Filer had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of RECORLEV®. The ANDAs each contained Paragraph IV certifications alleging that four of our Orange Book listed patents covering RECORLEV® that are 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 and/or will not be infringed by each ANDA Filer’s manufacture, use or sale of the generic product described in its respective ANDA submission.
On February 26, 2026, our wholly-owned subsidiaries, Xeris Pharmaceuticals, Inc. and Strongbridge Dublin Limited, filed a patent infringement lawsuit under the Hatch-Waxman Act in the United States District Court for the District of New Jersey against Torrent Pharmaceuticals Limited (along with its affiliate, "Torrent") and Somerset Therapeutics, LLC (along with its affiliates, "Somerset"). Our complaint alleges that, by filing the ANDAs, each of Torrent and Somerset has infringed RECORLEV®’s Orange Book patents included in its respective Paragraph IV certification, and seek an injunction preventing the FDA from granting final approval of the ANDA before the expiration of the asserted patents, and a permanent injunction to prevent Torrent and Somerset from commercializing a generic version of RECORLEV®, until the expiration of the asserted patents, including any applicable extensions and additional periods of exclusivity. No trial date has been set. The filing of the lawsuit within 45 days of receipt of each of the respective Notice Letters triggered an automatic stay of the FDA’s approval of each of the respective ANDAs for up to 30 months in accordance with the Hatch-Waxman Act.
ANDA litigation is common in the U.S. pharmaceutical industry. We may receive additional Notice Letters in the future from ANDA filers seeking approval of a generic version of RECORLEV® and may file additional ANDA lawsuits in the future. We intend to enforce and defend our intellectual property rights related to RECORLEV®.
We are also involved in various other legal proceedings arising in the normal course of business. Although the outcomes of these other legal proceedings are inherently difficult to predict, we do not expect the resolution of these other legal proceedings to have a material adverse effect on our financial position, results of operations, or cash flows.
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