Generic drugmakers Mylan, Teva and Ranbaxy have each launched copycat versions of Takeda’s blockbuster diabetes drug Actos in the US.
The companies are sharing 180-day exclusivity for their generic forms of the brand drug, which rakes in sales of around $2.7 billion a year in the country.
Actos (pioglitazone) is an antidiabetic pill that works by decreasing insulin resistance, and is approved for use in the US to improve glycemic control – alongside diet and exercise – in adults patients with type II diabetes mellitus.
“Controlling blood sugar levels is very important in preventing or reducing the long-term health complications of diabetes,” said Gregory Geba, director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research, commenting on the copycat approvals.
“Generic versions of this widely used product will offer affordable treatment options for patients who must manage this chronic and potentially serious condition,” he added.
According to market analyst Decision Resources, sales of drugs to treat type II diabetes in seven major markets – including the US – are set to nearly double by 2020, reaching almost $45 billion, as rates of diabetes continue to spiral out of control.
Watson left in the cold
Elsewhere, news of the launches will no doubt be leaving a rather bitter taste in the mouth of Watson Pharmaceuticals, which had also been hoping to launch its own version Actos but was held back by the US Food and Drug Administration, against which it has now filed a lawsuit.
The company said it believes that the FDA has “improperly denied” it a share of the 180 days’ exclusivity, and that as a result of this decision, Watson’s abbreviated new drug application (ANDA) could be delayed for up to six months.
