FDAnews
www.fdanews.com/articles/62443-pfizer-s-norvasc-patent-upheld-in-federal-court

PFIZER'S NORVASC PATENT UPHELD IN FEDERAL COURT

September 12, 2006

Generic drugmaker Synthon will have to wait until September 2007 to market a version of Pfizer's hypertension drug Norvasc unless it successfully appeals a recent ruling by North Carolina's Middle District court.

Pfizer announced Sept. 1 that the court ruled its patent on Norvasc (amlodipine besylate) is valid and infringed on by Synthon's generic product.

Norvasc generated $2.34 billion in sales during the first half of 2006 and is the most prescribed hypertension drug in the world, Pfizer said.

In another recent defeat for Synthon -- a U.S. subsidiary of Dutch company Synthon BV -- a jury in the U.S. District Court for the Eastern District of Virginia ruled that Pfizer's process for making amlodipine, the active ingredient in Norvasc, does not infringe on a patent held by Synthon. The jury also found the patent invalid on multiple grounds.