A U.S. District Court for the District of New Jersey issued an order on March 18, 2026 that postpones the bench‑trial originally scheduled for March 23. The trial, which will examine the validity of patents covering Catalyst Pharmaceuticals’ flagship Lambert‑Eaton myasthenic syndrome drug FIRDAPSE, has been moved to May 18, 2026. The defendant in the case is Hetero USA, Inc. The court’s decision gives Catalyst additional time to prepare its defense and to negotiate potential settlements with other parties that could affect the outcome.
The patents at issue are listed in the FDA Orange Book and are set to expire in 2032, 2034, and 2037. A prior settlement with Teva and Lupin has already established a generic entry date of February 25, 2035, provided the patents are found invalid. If the trial concludes that the patents are invalid, Catalyst could lose exclusive market rights earlier than 2035, which would directly threaten the $180 million-plus revenue stream that represents more than 90 % of the company’s 2023 income.
Catalyst’s financial dependence on FIRDAPSE makes the trial a critical event for investors. In 2023 the drug generated over $180 million in revenue, a figure that underscores its importance to the company’s overall profitability. The company has been pursuing diversification, acquiring U.S. commercial rights to FYCOMPA® in January 2023 and North American rights to AGAMREE® in July 2023, but the outcome of the patent trial remains a key risk factor for its long‑term revenue profile.
The delay also reflects a broader trend of stricter patent review in the U.S. pharmaceutical market. Catalyst has a history of litigating patent disputes, including a case against Jacobus Pharmaceutical over Ruzurgi. By postponing the trial, Catalyst gains time to strengthen its legal strategy and to explore settlement options that could preserve its market exclusivity and protect its valuation in a competitive environment.
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