Watson finds itself shut out of generic Actos launch

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The FDA's Friday approval of three authorized generic versions of Actos (pioglitazone) have put Takeda's type-2 diabetes treatment on the expired patent heap. Ranbaxy and Teva each issued their own authorized copies of the 15-mg, 30-mg and 45-mg formulations of the blockbuster. Mylan has been granted the right to distribute its own generic pioglitazone.

Watson is almost in the mix—it also sought a share in the 180-day period of generic marketing exclusivity but announced Wednesday that it's suing the FDA over a denial to its application. Watson planned to launch its generic version of Actos on August 17—the same day Ranbaxy, Mylan and Teva said they issued their copies—pursuant to a settlement agreement with Takeda on March 10, 2010. But the FDA's challenge to Watson's abbreviated new drug application (ANDA) could delay entry for up to six months, Watson said.

Teva also reiterated Friday it would launch an authorized generic of Actoplus Met, a combination of pioglitazone/metformin combination in 15mg/500mg and 15mg/850mg doses. Per a settlement the firms hammered out last year, Teva can begin marketing the two-for-one drug in December.

Meanwhile, Takeda continues to seek new ways to leverage its type-2 diabetes medication pioglitazone. After having marketed the standalone drug as Actos and as part of Actoplus, it's currently seeking FDA approval to use the drug as part of a combination marrying pioglitazone with DPP-IV inhibitor alogliptin. Alogliptin is known as Nesina in Japan.

The FDA served the company with a complete response letter over the combination drug April 25. Takeda answered on July 27 by providing additional data from Phase III trials .The company said in a statement that the supplementary data gave the agency information on close to 10,000 patients who have been treated with alogliptin. Approval would make it the first type 2 diabetes drug that merges a DPP-IV and thiazolidinendione in one tablet.

The company said in a statement that it expected the FDA will have reviewed the new data and the application by January 2013.

Pioglitazoneis also part of the type-2 diabetes drugs Sonias, which is sold in Japan. Sonias blends pioglitazone with glimepiride.

Correction: A previous version of this article said FDA review for the pioglitazone with DPP-IV inhibitor alogliptin was expected in January 2012. It should have read January 2013 and has been corrected above. The previous version said Mylan's generic pioglitazone was an authorized version. The company has been granted a license to distribute generic pioglitazone, but it is not considered an authorized generic. We regret the error.

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