AstraZeneca and its cholesterol drug Crestor have temporarily fended off competitors with a favorable court ruling. The pharmaceutical maker announced that a federal court declared a substance patent for rosuvastatin calcium, the active ingredient in Crestor, is valid and enforceable.
In 2007, several drug manufacturers filed Abbreviated New Drug Applications (ANDAs) with the FDA to market generic versions of Crestor. AstraZeneca and Shionogi, owner of the patent, filed patent infringement lawsuits against eight manufacturers: Apotex, Aurobindo, Cobalt, Mylan, Par, Sandoz, Sun and Teva. In 2010, the U.S. District Court for the District of Delaware found the patent valid, enforceable and infringed by the eight generic defendants, a ruling that was then upheld by the Court of Appeals for the Federal Circuit.
The defendants can seek a rehearing or review by the U.S. Supreme Court. Unless the ruling is reversed, none of the ANDAs filed by Apotex, Aurobindo, Cobalt, Glenmark, Mylan, Par, Sandoz, Sun, Teva and Torrent can be approved, according to AstraZeneca.
Crestor is one the company’s top selling drugs, bringing in more than $6.6 billion in sales in 2011. The patent expires in 2016.