CPHI: This recent ruling against AstraZeneca could be the green light to the Chinese SFDA that this could be a lower risk approval for CPHI's generic Crestor.
"AstraZeneca Loses Battle to Bar Generic Forms of Crestor AstraZeneca Plc lost a U.S. appeals court bid to protect its best-selling drug, Crestor, from generic competition until as late as 2021. A judge was correct to dismiss AstraZeneca’s lawsuits against Teva Pharmaceutical Industries Ltd. and other generic- drug makers over patents on the cholesterol drug that expire in 2018 and 2021, the U.S. Court of Appeals for the Federal Circuit in Washington said yesterday. The court is still considering the validity of the main patent on Crestor, which expires in 2016. Crestor generated $6.6 billion in sales last year for London-based AstraZeneca, almost 20 percent of the company’s total revenue. The two patents cover methods of using the active ingredient rosuvastatin calcium for certain types of patients. The generic-drug companies had sought approval to sell copycat versions only for treatments not covered by the patents. The appeals court ruled that, based on that pledge, AstraZeneca didn’t have the right to sue to block the competition."
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