FDA sues Cephalon for generic blocking

The US Federal Trade Commission has filed a complaint in federal district court against drugmaker Cephalon alleging anticompetitive conduct that is preventing competition to its branded drug Provigil (modafinil). This is approved for the treatment of excessive spleepiness in people with sleep apnea, narcolepsy and shift-work sleep disorder and generated sales of some $800.0 million for the company in 2007, according to the agency.

The conduct includes paying four firms to refrain from selling generic versions of Provigil until 2012. Cephalon's anticompetitive scheme, the FTC states, denies patients access to lower-cost, generic versions of the drug and forces consumers and other purchasers to pay hundreds of millions of dollars a year more for it, said the FTC.

According to the Commission's complaint, filed in the US District Court for the District of Columbia, Cephalon entered into agreements with four generic drug manufacturers that each planned to sell a generic version of Provigil. Each of these had challenged the only remaining patent covering the drug, one relating to the size of particles used in the product. The complaint charges that Cephalon was able to induce each of the generic companies to abandon its patent challenge and agree to refrain from selling a generic version until 2012 by agreeing to pay the firms a total amount in excess of $200.0 million. In so doing, Cephalon achieved a result that assertion of its patent rights alone could not.