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Mylan sues FDA for rights to generic medication

| Friday, April 6, 2012

Mylan Inc. claimed in a federal lawsuit filed on Thursday in the District of Columbia that the Food and Drug Administration should have awarded its Mylan Pharmaceuticals Inc. unit, rather than a competitor, the exclusive right to sell a generic version of Provigil for the next six months.

Provigil is the brand name for modafinil, a drug used to improve wakefulness in people who have trouble staying awake because of narcolepsy, obstructive sleep apnea or working night shifts or rotating shifts.

Mylan Pharmaceuticals of Morgantown, W.Va., is a subsidiary of Canonsburg-based Mylan Inc.

The FDA awarded the 180-day exclusivity to Jerusalem-based Teva Pharmaceutical Industries Ltd. Teva bought Cephalon Inc., the manufacturer of Provigil, in 2011. Cephalon is based in Chester County, near Philadelphia. Provigil has more than $1 billion in annual sales, according to Teva.

Mylan contends that Teva's purchase of the company holding the two patents for Provigil makes it ineligible to hold the exclusive right to sell the generic version for the next six months. Allowing it to do so would undermine the federal law that encourages competition in generic drugs, the lawsuit states.

"A conclusion that Teva is permitted to obtain 180-day exclusivity in this situation would lead to endless game playing and absurd results," Mylan said in its lawsuit.

Mylan had a license with Cephalon to start marketing a generic version of the drug today, but the FDA decision gives Teva complete control of the market, the lawsuit states. That agreement was made before Teva bought Cephalon, according to the lawsuit.

The FDA declined to comment.

Teva on Monday filed its own federal lawsuit against the FDA because the agency had signaled it might award the 180-day exclusivity to someone else, according to Teva's complaint. U.S. District Judge Richard Robert dismissed that lawsuit yesterday based on Teva's attorneys' confirming that the FDA had awarded it the right to exclusively market the generic.

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