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Takeda Pharmaceutical Co., the Japanese drug company, is being sued by more Actos® users whose treatment for diabetes may cause bladder cancer, but marketing of Actos continues in the U.S. Weitz & Luxemberg attorney Paul J. Pennock noted his firm represents 1,200 former Actos users, and he expected the number of lawsuits could rise to 10,000 due to the effects of Actos on people whose diabetes has been treated with the drug. In June 2011, Germany joined France in suspending the top-selling Takeda drug, Actos in their markets, whose sales topped $4.8 billion so far this fiscal year, due to the threat of bladder cancer occurring in its users.

Pioglitazone hydrochloride, also known as Actos, was developed by Takeda primarily to help treat Type 2 diabetes mellitus, and was distributed and marketed since 1999 in the U.S. by Eli Lilly & Co. and GlaxoSmithKline. Actos oral tablets were marketed as a medication which would help the body use insulin more efficiently. Accompanying the drug is a host of contraindications about the use of pioglitazone and long lists of possible negative side-effects and other medications with which pioglitazone may interact. Users are cautioned to have regular blood tests to monitor any possible damage to their liver.

According to a December 1, 2011, article by the Associated Press in The Indianapolis Star, Eli Lilly, one of Actos’ distributors’, lobbying costs in the third quarter of 2010 approached $2.3 million “focusing on patent reform, trade issues and hospital discounts.” A brief notation in an article by Melly Alazraki in The Daily Finance, February 27, 2011, says Actos is one of the blockbuster drugs that will lose its patent in 2012. According to Alazraki, “Once drugs lose patent protection, lower-price generics quickly siphon off as much as 90% of their sales.” According to that article, Actos’ (first three quarters) 2010 U.S. sales are shown as approximately $3.35 billion. So the manufacturer and distributors should expect hefty losses when the drug goes generic.

So notwithstanding Takeda’s patent for Actos actually expiring last January 2011, Takeda (and possibly Lilly and GlaxoSmithKline) may have their hands full financially battling the forthcoming tide of Actos lawsuits. No matter that Takeda has already agreed with several generic drug marketers, Ranbaxy, Watson and Mylan on the future marketing of a generic form of Actos.

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