Israeli generic giant Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA; TASE:TEVA) has obtained tentative marketing approval from the US Food and Drug Administration (FDA) for a generic version of Pioglitazone, made by Eli Lilly & Co. (NYSE:LLY) and Takeda Pharmaceutical Company Ltd. (TSE:4502). Pioglitazone improves the functioning of the liver, muscles, and fatty tissue in diabetics. Sales of ethical Pioglitazone totaled $1.4 billion in 2004.
Teva obtained marketing approval for 15-mg, 30-mg, and 45-mg tablets.
Clal Finance Batucha analyst Yisca Erez said Teva probably did not obtain exclusivity to market generic Pioglitazone, and the tentative marketing approval was therefore less significant. She said three other companies, in addition to Teva, probably obtained tentative marketing approval for the drug, including Watson Pharmaceuticals (NYSE:WPI) and Mylan Laboratories (NYSE; XETRA: MYL).
Erez also predicted that Teva would begin marketing generic Pioglitazone no earlier than late 2006, and possibly later. Given that Teva will not have exclusive marketing rights to the drug, annual sales, once marketing begins, will total $110-120 million.
Erez added that a legal battle was likely over Pioglitazone patents, similar to previous cases.
Published by Globes [online], Israel business news - www.globes.co.il - on February 9, 2006