Mylan Sues FDA for Rights to Generic Medication

Article excerpt

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. …