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Teva Pharmaceuticals Inc. finds itself at the center of a high-stakes legal battle as Jazz Pharmaceuticals Inc. has filed a lawsuit accusing Teva of infringing on its patent for the narcolepsy drug Xywav. The complaint, lodged Tuesday in a New Jersey federal court, alleges that Teva’s actions violate the intellectual property rights of Jazz Pharmaceuticals.

Teva Narcolepsy Drug Suit : Patent Dispute Heats Up

Xywav, an oral solution containing calcium, magnesium, potassium, and sodium oxybates, is used to manage narcolepsy symptoms such as cataplexy and excessive daytime sleepiness. Jazz Pharmaceuticals, headquartered in Dublin, Ireland, was granted a patent for Xywav by the U.S. Patent and Trademark Office on May 21, 2024. This patent, identified as U.S. Patent No. 11,986,446, is the crux of the legal dispute.

According to the complaint, Teva, based in Parsippany, New Jersey, has submitted an abbreviated new drug application to the U.S. Food and Drug Administration (FDA). This application seeks approval to produce, import, and sell a generic version of Xywav before the patent's expiration.

Allegations and Legal Demands

Jazz Pharmaceuticals contends that Teva’s actions could lead to substantial and irreparable harm if not halted. The company claims that Teva’s proposed generic product infringes on its patent rights and seeks judicial intervention to prevent this.

In the complaint, Jazz reveals that Teva informed the company no earlier than July 15, 2024, of its stance that Jazz’s patent claims are either invalid or not infringed by Teva’s proposed product. Jazz is demanding a court judgment affirming patent infringement, an order delaying the FDA approval of Teva’s product until after the patent’s expiration, and both preliminary and permanent injunctions against Teva’s production and sale of the generic drug. Additionally, Jazz seeks damages and reimbursement for legal fees.

Legal Representation and Next Steps

Charles M. Lizza, William C. Baton, Sarah A. Sullivan, and Alexander L. Callo of Saul Ewing LLP represent Jazz Pharmaceuticals in this case. At the time of the filing, Teva’s legal counsel information was not immediately available.

The outcome of this lawsuit could significantly impact the availability of generic versions of Xywav and set a precedent for patent disputes in the pharmaceutical industry.