Court ruling in orphan drug lawsuit reframes outlook on market exclusivity

On Sept. 29, a federal judge dismissed a lawsuit from Catalyst Pharmaceuticals against the FDA and Jacobus Pharmaceuticals over the approval of a rival drug for a rare autoimmune disease — a ruling that disputes the “exclusivity” of the Orphan Drug Act.In 2018, Catalyst Pharmaceuticals was awarded FDA approval and granted orphan drug status for amifampridine (Firdapse), the first treatment for pediatric patients with Lambert-Eaton Myasthenic Syndrome. Catalyst was under the assumption that market exclusivity was part of the orphan drug designation.However, in 2019, the FDARead More

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