Watson Can Sell Generic Actos Now, U.S. Judge Rules

Watson Pharmaceuticals Inc. may begin immediately marketing a generic version of Takeda Pharmaceutical Inc.’s diabetes drug Actos, a federal judge ruled, handing the U.S. Food and Drug Administration a defeat.

U.S. District Judge Amy Berman Jackson in Washington today overturned an FDA decision that kept Watson from joining a period of shared exclusivity granted to the companies that are first to file for the right to market generic versions of branded drugs. Actos is the world’s top-selling diabetes medicine.

Jackson ordered the FDA to immediately allow Watson to participate in what remains of the 180-day exclusivity period previously awarded to competitors Mylan Inc. and Ranbaxy Laboratories Ltd. Only the order was made public. Jackson sealed her opinion because of trade secrets disclosed in the litigation, pending arguments by the parties.

Watson sued the FDA in August, claiming the agency’s decision to bar it from participating in the exclusivity period was “arbitrary, capricious and contrary to law,” according to the company’s complaint.

Sandy Walsh, a spokeswoman for the FDA, said she was unable to comment immediately on the ruling.

Actos is the trade name of pioglitazone hydrochloride, the world’s top-selling diabetes medicine marketed by Osaka, Japan-based Takeda. Actos had sales of about $3.4 billion in 2009, Watson said in court papers, citing market researcher IMS Health.

Patent Settlement

Watson and its two competitors reached a settlement with Takeda in 2010 after “protracted” patent litigation, which allowed it to start selling the generic version of the drug on Aug. 17, 2012, according to court documents. Based on the settlement and communications with the FDA, the Parsippany, New Jersey-based company was preparing to sell its pioglitazone product and promised delivery to customers, according to the complaint.

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

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.

The case is Watson Laboratories Inc. v. Sebelius, 1:12-cv-01344-ABJ, U.S. District Court, District of Columbia (Washington).

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