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Watson Pharmaceuticals Sues FDA, Wins Right to Sell Generic Actos

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Watson Pharmaceuticals has won its lawsuit against the U.S. Food and Drug Administration (FDA), allowing it to immediately begin selling its generic version of the type 2 diabetes drug Actos (pioglitazone).

The decision means Watson will profit during the second half of the 180-day marketing exclusivity period granted to some manufacturers of generic prescription drugs when the name-brand patent expires.

The first generic form of Actos hit the market in August. Mylan, Ranbaxy and Teva are already selling generic forms of the drug, as they battle for a piece of the Actos market, which had U.S. sales of $2.7 billion from August 2011 to August 2012. A generic form of the combination drug ACTOplus met will launch in December.

Drug Manufacturers Battle for Right to Sell Generic Actos

Drug manufacturers have been challenging Takeda Pharmaceuticals over its Actos patent for many years. In 2004, Mylan received tentative approval from the FDA to sell a generic form of Actos, but Takeda sued and won. Mylan, Watson, Ranbaxy and Teva challenged the patent again in 2010, and Takeda settled with the companies, setting an August 2012 release date for the first generic drug.

The 1984 Hatch Waxman Act requires the FDA to grant exclusivity for 180 days to the first companies that produce generic equivalents and file for approval of drugs before original patents expire. This type of agreement requires consent from the FDA and the manufacturer, and typically outlines a cash payment or royalty compensation for the branded manufacturer.

Mylan, Ranbaxy and Teva received FDA approval to sell their generic versions, but Watson did not. On Aug. 15, 2012, Watson responded by suing the FDA, stating that the FDA's denial was "arbitrary, capricious and contrary law."

Paul Bisaro, Watson's president and CEO, said in a press release that the "FDA has refused to grant shared exclusivity, and seeks to unnecessarily delay the launch of Watson's generic Actos product, with potential harm to consumers who may face constraints on supply as a result of this action."

Last week, U. S. District Judge Amy Jackson in Washington decided in favor of Watson. Mylan appealed the ruling, but was denied.

Generic Actos Could Mean More Bladder Cancer Cases

As more companies produce Actos — and at cheaper prices — more people with type 2 diabetes may be at risk for developing bladder cancer, just one of the many side effects associated with Actos.

Long-term use of Actos can increase the risk of developing bladder cancer by 80 percent, according to one study. The treatment for bladder cancer can be as serious as chemotherapy, and may even require the removal of a diseased bladder.

While bladder cancer is one of the more severe side effects linked to Actos, there have also been many cases of eye problems, bone fractures, liver failure and congestive heart failure. Due to the extent of these maladies, many people have sued Takeda. The number continues to rise, with up to 10,000 lawsuits expected to be filed against Takeda, according to Bloomberg.

Despite these risks, Actos remains the world's best-selling diabetes drug.