Teva’s Cephalon Reaches $125m Settlement With 48 States Due to Generic Delays

Regulatory NewsRegulatory News | 04 August 2016 |  By 

Teva Pharmaceutical’s Cephalon and state attorneys general on Thursday announced a $125 million, 48-state settlement after an investigation into the company’s delaying of generic versions of its top product.

Cephalon, which denies any wrongdoing and was acquired by Teva in 2011, was accused of delaying generic versions of its sleep disorder drug Provigil (modafinil).

The settlement with every state and Washington, DC (but not including California and Louisiana) follows a $1.2 billion settlement Cephalon made with the Federal Trade Commission from May 2015.

According to the New York Attorney General, as patents preventing generic competition to Provigil neared expiration, an investigation found that Cephalon intentionally defrauded the Patent and Trademark Office to secure an additional patent, which a court subsequently deemed invalid and unenforceable. 

Prior to that ruling, Cephalon allegedly delayed generic competition for almost six years by filing patent infringement lawsuits, which it then settled by paying competitors to delay sale of their generic versions of Provigil until at least April 2012. 

The settlement, which is subject to court review, includes $35 million for consumers who bought Provigil.

The court review is expected to be provided by Judge Mitchell Goldberg of the Eastern District of Pennsylvania, who is overseeing other litigation concerning Provigil against Cephalon and others.

Settlement Agreement


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