PharmPro has reported that Teva Pharmaceuticals Industries is to pay $1.2 billion in order to settle legal claims that one of its subsidiaries (Cephalon Inc.) blocked the launch of low-cost generic versions of the blockbuster sleeping pill Provigil. Provigil (modafinil) is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.
The drug should be taken with caution. A U.S. National Institute on Alcohol Abuse and Alcoholism (NIAAA) study highlighted “the need for heightened awareness for potential abuse of and dependence on modafinil in vulnerable populations.” This warning is due to the drug’s effect on dopamine in the brain’s reward center.
The Teva settlement is is part of the U.S. government’s campaign against a big pharma practice termed “pay-for-delay” deals. Some pharmaceutical companies argue that this approach helps to resolve costly patent litigation between branded products and their generic competitors. However, the U.S. Federal Trade Commission argues that such deals keep cheaper forms of medicines (known as generics) off the market. The net result of this is to increase costs for consumers and hospitals.
With this specific case, the FTC stated that Cephalon paid four generic drug manufacturers over $300 million to delay launching their low-cost versions of Provigil drugs until 2012. Teva, agreeing to the act of “reverse settlements”, has paid out and the case will not be pursued further. Denise Bradley, a spokeswoman for Teva told The New York Times: “We are pleased to have reached an agreement with the government.”
