Xeris Biopharma Holdings, Inc. (XERS) filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Torrent Pharmaceuticals Limited and Somerset Therapeutics, LLC, seeking to block the manufacture, use and sale of a generic version of its levoketoconazole therapy Recorlev.
The complaint cites four patents—U.S. Patents 11,020,393; 11,278,547; 11,903,940; and 12,377,096—listed in the FDA’s Orange Book and scheduled to expire in March 2040. Xeris seeks an injunction that would keep the generic product off the market until the patents expire, protecting the company’s exclusive rights to Recorlev.
Recorlev has become a key driver of Xeris’s revenue, generating $139 million in full‑year 2025 sales and $45 million in Q4 2025. The drug’s market is sizable, with the Cushing’s syndrome treatment segment projected to grow from $1.7 billion in 2026 to $2.8 billion by 2033. Protecting the patents therefore preserves a significant share of a growing market and safeguards the company’s profitability.
Torrent and Somerset argue that the patents are invalid, unenforceable or will not be infringed, and have filed Abbreviated New Drug Applications (ANDAs) to the FDA. If the court sides with the generic filers, Xeris could lose exclusive sales of Recorlev before the 2040 expiration, potentially eroding its revenue base and exposing the company to competitive pricing pressure.
The lawsuit has already drawn attention from investors and analysts. While the company’s stock has traded below key moving averages, the filing signals a defensive strategy to maintain market share and protect future cash flows. Xeris’s management has emphasized confidence in its intellectual‑property portfolio and its ability to defend the patents, underscoring the importance of Recorlev to the company’s long‑term strategy.
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