Ranbaxy debuts authorized Actos generic in USA, followed by Teva and Mylan

The US subsidiary of Ranbaxy Laboratories (AB: BO), India’s largest drugmaker, has launched authorized generic pioglitazone hydrochloride tablets in the US market, under an agreement with the local subsidiary of originator Japanese drug major Takeda Pharmaceuticals (TYO: 4502), which markets the type 2 diabetes drug as Actos, which generated total annualized US sales of $2.7 billion, according to IMS Health data for the 12 months to June.

Bill Winter, vice president, trade sales and distribution, North America, at Ranbaxy, said: “Ranbaxy is making available the full range of generic pioglitazone in 15mg, 30mg, and 45mg tablets. The introduction of generic pioglitazone hydrochloride tablets is a significant and important addition to our portfolio of antidiabetic products in the USA. The launch further complements our resolve to bring high quality, affordable generic medicines as early as possible to the US health care system.”

The news on Friday came just two days after US generic drugmaker Watson filed a law suit against the US Food and Drug Administration, challenging the agency for improperly denying the company's shared exclusivity for Actos despite the fact that Watson had directly followed directions received from the FDA concerning its Paragraph IV certification to certain patents at the time of its 2003 ANDA filing (The Pharma Letter August 16). Watson had planned to launch its generic version of Actos on August 17, under a settlement agreement on March 10, 2010 with Takeda.