157  0 Kommentare Catalyst Pharmaceuticals Receives Two New U.S. Patent Allowances For FIRDAPSE

New Patents Further Reinforce the FIRDAPSE (amifampridine) Intellectual Patent Portfolio

CORAL GABLES, Fla., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases, today announced that the Company has received notification by the United States Patent and Trademark Office ("USPTO") that two additional patents covering FIRDAPSE (amifampridine) Tablets 10 mg, were allowed and will be granted within the next two months. These new patents are for claims associated with the unique and novel, previously unknown, bioavailability of FIRDAPSE under fasting and fed conditions of dosing. FIRDAPSE is the only approved treatment available in the U.S. for Lambert-Eaton myasthenic syndrome.

"We are very pleased to receive these patent notifications from the USPTO. This milestone reaffirms our unwavering dedication to advancing our core objectives, which are crucial in strengthening and maintaining the ongoing commercial success of our flagship product, FIRDAPSE," stated Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst. "Aligned with our portfolio strategy, we remain committed to advancing our core objectives to reinforce and safeguard the sustained commercial viability of FIRDAPSE, which currently benefits from patent exclusivity protection in the United States until 2037."

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"These patent allowances strengthen our cumulative understanding of the uniqueness of FIRDAPSE and bolster its strong intellectual property estate offering enhanced patent protection," stated Dr. Steven Miller, Chief Operating Officer and Chief Scientific Officer of Catalyst. "These two new patents, with expiry dates out to mid-2032, cover claims related to the product's novel and unique bioavailability when administered under fasting and fed dosing conditions, further strengthening our NAT2 family of patents. We expect these patents to be granted within two months. Preparations are already in motion to include these additional FIRDAPSE patents in the FDA Orange Book post-grant, bringing the total listed patent count to eight."