A New Jersey federal judge has denied Tris Pharma Inc.’s motion to dismiss a patent infringement lawsuit filed by Jazz Pharmaceuticals Ireland Limited. The suit alleges that Tris Pharma’s attempt to market a generic version of Xyrem, a narcolepsy treatment, infringes on Jazz’s patents.
In January 2026, Tris Pharma notified Jazz Pharmaceuticals of its submission of a Section 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), referencing Xyrem and Xywav as the listed drugs. The notice included a Paragraph IV certification challenging the validity or enforceability of seven patents associated with Xyrem and fifteen patents related to Xywav. These patents cover methods of treatment involving the administration of Xyrem or Xywav alongside other medications, as well as the composition and use of Xywav. ([sec.gov](https://www.sec.gov/Archives/edgar/data/1232524/000123252426000025/jazz-20260331.htm?utm_source=openai))
In response, Jazz Pharmaceuticals initiated two patent infringement lawsuits against Tris Pharma on February 20, 2026, in the U.S. District Court for the District of New Jersey. The complaints assert that Tris Pharma’s NDA filing constitutes infringement of Jazz’s patents listed in the FDA’s Orange Book for both Xyrem and Xywav. Jazz seeks a court order delaying the FDA’s approval of Tris Pharma’s NDA until after the expiration of the last asserted patent. ([dockets.justia.com](https://dockets.justia.com/docket/new-jersey/njdce/2%3A2026cv01740/592181?utm_source=openai))
Tris Pharma filed motions to dismiss the lawsuits on April 24, 2026. However, the court has now denied these motions, allowing the litigation to proceed. This decision underscores the ongoing legal challenges generic pharmaceutical companies face when attempting to enter markets dominated by patented drugs.
Jazz Pharmaceuticals has a history of defending its Xyrem patents. In a separate case, the company reached a $195 million settlement in October 2025 to resolve allegations that it unlawfully blocked generic competition for Xyrem, leading to significant price increases over seven years. ([legalclarity.org](https://legalclarity.org/xyrem-price-abuse-class-action-allegations-and-settlement/?utm_source=openai))
The current litigation between Jazz Pharmaceuticals and Tris Pharma highlights the complexities of patent law in the pharmaceutical industry, particularly concerning the balance between innovation and generic competition. As the case progresses, it will be closely watched by industry stakeholders for its potential impact on market dynamics and patent enforcement strategies.