Singapore, Jul 2, 2009: Japan's Astellas Pharma has announced that Boehringer Ingelheim Pharmaceuticals has submitted the data for Flomax (generic name: tamsulosin hydrochloride, brand name in Japan: Harnal) from a study involving pediatric patients with neurogenic bladder to the US Food and Drug Administration (FDA) on June 25, 2009.

 

Tamsulosin hydrochloride was invented and developed by Astellas for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) and is said to have been marketed in approximately 90 countries since it was launched in Japan in 1993. In the US, under a license from Astellas, BIPI has been marketing the product since 1997 under the brand name Flomax. Since October 2004, Astellas Pharma US, a US subsidiary of Astellas, has been co-promoting the product with BIPI.

 

According to Astellas, the studies for Flomax in pediatric patients with neurogenic bladder were conducted in accordance with a pediatric Written Request issued by FDA in January 2006. Pediatric exclusivity is expected to be granted allowing an additional six months of market exclusivity for Flomax if FDA determines that the submitted study reports adequately respond to the Written Request.

The Flomax US substance patent expires in October 2009; however, if the data are officially accepted, the period of market exclusivity for Flomax will be extended to April 2010.