FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

Spring Pharma: Shkreli, Retrophin Illegally Stifled Thiola Generics

Nov. 2, 2018

Spring Pharmaceuticals sued incarcerated ex-pharma CEO Martin Shkreli and his former biopharmaceutical company Retrophin for blocking generics of its kidney stone drug Thiola.

Since 2014, the defendants have maintained an illegal monopoly on the drug, which is used to treat the kidney ailment cystinuria, according to the complaint, filed in the Eastern District of Pennsylvania.

Thiola is the only FDA-approved drug with tiopronin as an active ingredient. The drug is currently off-patent, but Shkreli and Retrophin held off generic competition through unlawful exclusionary conduct, according to Spring, which formed in November 2017 and selected a generic version of Thiola as its first product. “Under Shkreli's leadership, Retrophin's business model was to acquire off-patent, sole-source drugs, move the drugs into a restricted distribution system designed to prevent generic entry, and raise their prices by staggering amounts,” the complaint alleges.

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