Teva to Pay $512M to Settle Antitrust Claims

     PHILADELPHIA (CN) -Teva Pharmaceuticals agreed to pay $512 million to settle claims its Cephalon subsidiary bought out prospective generic drug makers to maintain the market dominance of its wakefulness drug, Provigil.
     The settlement is the largest ever to be paid to drug wholesalers and retailers over the alleged purposeful delaying of generic drugs..
     Previously that distinction belong to Abbott Laboratories, which along with French partner Fournier Industrie et Sante, paid $250 million to settlement allegations it bought out generic competition for its cholesterol drug Tricor.
     The Supreme Court in the 2013 case FTC v. Actavis ruled the practice can violate antitrust laws and cleared the Federal Trade Commission to pursue such cases.
     The plaintiffs in the case alleged Cephalon entered with settlements of patent lawsuits with Mylan Inc. and Ranbaxy Laboratories, among others, to keep generic versions of PRovigil off the market until 2012.
     U.S. District Judge Mitchell Goldberg still has to approve the settlement, which allows Teva to avoid an explicit admission of guilt.
     Provigil, a drug originally intended to treat narcolepsy, turned the previously little known Cephalon into a pharmaceutical powerhouse in the late 2000s. As the company faced expiring patents onProvigil, Cephalon, in a practice known as “evergreening,” introduced Nuvigil, another “wakefulness promoting agent” that works on the same mechanisms of the brain.
     The reverse-settlement is one of two major legal fronts facing the Teva subsidiary. On April 15, a federal judge allowed a case filed by a handful of states to move forward against the company for violating the False Claims Act by illegally marketing Provigil and Nuvigil for uses not approved by the Food and Drug Administration.
     In 2008, Cephalon pleaded guilty to criminal charges of such off-label marketing.
     In a statement provided by Denise Bradley, Teva Pharmaceuticals’ Senior Vice President of Global Corporate Reputation, the company confirmed it reached a settlement with a proposed class of Direct Purchaser Plaintiffs in the modafinil antitrust litigation, King Drug Company of Florence v. Cephalon, et al., for $512M.
     “This suit was brought as a result of a series of settlement agreements Cephalon entered into in late 2005 and early 2006 to settle patent litigation over its Provigil product. Teva acquired Cephalon in 2011. Teva is pleased with the terms of the settlement. We have no further comment pending additional ongoing litigation,” the statement said.

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