Court overturns FDA’s decision barring Watson from making generic Actos

actos pioglitazone hydrochloride Court overturns FDA’s decision barring Watson from making generic Actos  Prescriptions of Takeda Pharmaceutical’s blockbuster diabetes drug Actos (pioglitazone) have plummeted since a number of clinical studies linked the drug to a significantly higher risk of bladder cancer in patients, but those safety concerns haven’t dissuaded a group of other drug makers from fighting over the rights to make their own generic versions as Takeda’s Actos patent expires.

On Monday, U.S. District Judge Amy Berman Jackson in Washington overturned the U.S. Food and Drug Administration’s (FDA) decision to bar Watson Pharmaceuticals from joining a period of shared exclusivity the agency grants to companies that are first to file for the rights to manufacture generic versions of brand-name drugs.

Under the Hatch-Waxman Act, generic drug makers are awarded six months of limited competition, giving them a head start on developing marketing and distribution networks for the drug, which is usually sold during that time at near brand-level prices. The Act was designed to encourage quick applications for FDA approval of the generic and promote lower drug prices.

New Jersey-based Watson sued the FDA in August, asserting the agency’s decision to keep it from participating in the 180-day exclusivity period “arbitrary, capricious and contrary to law,” according to the company’s complaint. In her ruling, Judge Jackson ordered the FDA to allow Watson to participate in the 180-day exclusivity period immediately.

Federal regulators originally awarded the exclusivity to Watson’s competitors Mylan Inc. and Ranbaxy Laboratories. The judge’s opinion on the matter has been sealed to protect trade secrets disclosed during the litigation.

Watson’s complaint stated that in 2010, it and the two competitors reached an agreement with Takeda during patent litigation to produce and start selling a generic version of Actos on August 17, 2012. Court documents alleged Watson was preparing to sell its pioglitazone drug and promised delivery to customers when the FDA blocked it.

Watson’s complaint stated that the FDA “informed Watson it had reached a decision to award another filer or filers a period of 180-day exclusivity,” but that the agency “has failed to provide any explanation or basis for its determination.”

Generic-drug companies are given six months of limited competition under the Hatch-Waxman Act, passed in 1984 to promote quick applications that will lower the price of drugs. The concession gives drugmakers the ability to keep prices close to the branded level and set up distribution networks before others enter the market. When more than one company files at the same time, they may be granted shared exclusivity by the FDA.

Meanwhile, Pennsylvania-based Mylan filed a motion Wednesday in the U.S. District Court for the District of Columbia to stay the order in favor of Watson.

“Mylan is disappointed in yesterday’s ruling regarding pioglitazone, and we believe the court erred in its decision by directly contravening the Hatch-Waxman Act,” Mylan CEO Heather Bresch said. “Mylan does not believe Watson is entitled to participate in Mylan’s 180-day exclusivity period in relation to this product, and we intend to pursue this case vigorously, including seeking expedited relief from the appellate court if necessary.”


Bloomberg BusinessWeek
Mylan Inc.