Takeda Launches Sleeping Pill in U.S.

Tokyo, Sept. 27 (Jiji Pres)–Takeda Pharmaceutical Co. said Tuesday it has started selling the Rozerem sleeping pill in the United States as part of an effort to offset the future loss of patent protection for its mainstay drugs in the crucial U.S. market.

Rozerem is the first prescription sleep medication that has shown no evidence of abuse or dependence in clinical studies, the company said.

Demand for drugs to treat insomnia in Japan, the United States and Europe is expected to grow to 5.69 billion dollars, or about 636 billion yen, in 2013, a 2.4-fold jump from the 2003 level.

Rozerem, Takeda’s first new drug in the U.S. market in six years, was approved by the U.S. Food and Drug Administration in late July and is in the clinical trial phase in Japan and Europe.

Takeda hopes to nurture Rozerem into a blockbuster drug as it is poised to begin losing patent protection for four mainstay drugs in the U.S. market in 2009.

Once patent protection is removed, these drugs are set to face intense competition from low-cost generic drugs.

An estimated 60 million people suffer from insomnia in the United States, although most of them remain undiagnosed and untreated, Takeda said.END