ASTELLAS PURSUES PEDIATRIC EXCLUSIVITY TO EXTEND FLOMAX PATENT

Astellas Pharma is moving to extend patent protection for its enlarged-prostate treatment Flomax, a blockbuster drug that generated more than $1 billion in sales last year, the company said.

"Although the substance patent expires in the U.S. in October 2009, we are now conducting clinical trials for pediatric use by which we hope to obtain marketing exclusivity for another six months," company representative Saori Furukawa said.

The company disclosed its plans to obtain pediatric exclusivity after a court decision blocked efforts by Ranbaxy Laboratories to launch generic Flomax before the patent expires. Last week the U.S. District Court for the District of New Jersey ruled that Ranbaxy's generic tamsulosin hydrochloride infringes on the Flomax patent held by Astellas.

The brand company has not received notice of any other generic firms filing an abbreviated new drug application with a Paragraph IV certification, according to Furukawa. She said the company is prepared to enforce its "patent against those companies which attempt to launch generic tamsulosin prior to the expiration of our patent."

Ranbaxy has appealed the ruling, according to Boehringer Ingelheim Pharmaceuticals, which distributes the drug for Astellas.