Generic Actos Launched by Mylan, Teva and Ranbaxy

Mylan, Teva and Ranbaxy announced on Friday that they have each launched generic forms of Takeda’s blockbuster type 2 diabetes drug Actos in the US.

The generic drugmakers are sharing 180-day exclusivity for the generic versions of the branded medication, which receives in sales of roughly $2.7 billion a year across America.

Actos (pioglitazone) is an anti-diabetic pill that reduces insulin resistance, and is approved for use in the US to improve glycemic control (in conjunction with diet and exercise)  in adult patients with type 2 diabetes mellitus.

“Controlling blood sugar levels is very important in preventing or reducing the long-term health complications of diabetes,” commented Gregory Geba, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.

“Generic versions of this widely used product will offer affordable treatment options for patients who must manage this chronic and potentially serious condition,” he noted.

According to market analyst Decision Resources, sales of drugs to treat type 2 diabetes in seven major markets, including America, are expected to almost double by 2020, reaching nearly $45 billion, as rates of diabetes continue to spiral out of control.

Watson Unable to Launch Generic

Watson Pharmaceuticals had also hoped to launch their own version of Actos but were postponed, unable to release their generic version, by the US Food and Drug Administration (FDA), against which they have now filed a lawsuit.

Watson believes that the FDA has “improperly denied” them a share of the 180 days’ exclusivity, and that as a result of this decision, Watson’s abbreviated new drug application (ANDA) might be postponed for up to six months.


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