FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Lawsuit Accuses Ranbaxy of Manipulating Generic Exclusivity

Nov. 16, 2018

A Pennsylvania benefits fund filed suit against generic drugmaker Ranbaxy claiming it used its exclusive status to fraudulently block other generics for several drugs, including Nexium (esomeprazole), Diovan (valsartan) and Valcyte (valganciclovir).

Ranbaxy entered into a plea agreement with the federal government in 2013 over allegations it falsified NDAs for generics to maintain its valuable “first-to-file” status.

Despite the opportunity to bring the excepted generic application drugs to market, the company’s “obstinate delay tactics and excessive compliance failures continued,” according to the complaint, filed in the Eastern District of Pennsylvania.

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