AstraZeneca Sues to Protect Crestor Patent

AstraZeneca has filed patent infringement suits against seven companies that submitted abbreviated new drug applications (ANDAs) seeking to market generic versions of its cholesterol drug Crestor before the patents expire.

After first receiving notice of an ANDA containing a Paragraph IV challenge from Cobalt Pharmaceuticals, AstraZeneca received notices from eight other generic firms.

Each notice contained a Paragraph IV certification alleging that one or more of AstraZeneca’s three Orange Book-listed patents for Crestor (rosuvastatin calcium) are not infringed on or otherwise invalid or unenforceable.

Based on these various filings, AstraZeneca filed separate suits Dec. 11 in the U.S. District Court for the District of Delaware against Aurobindo Pharma, Apotex, Cobalt, Par Pharmaceutical, Sandoz, Mylan and Sun Pharmaceutical Industries alleging infringement of the ’314 patent, which expires in 2016. The company’s other two patents expire in 2020 and 2021.

AstraZeneca did not sue Teva Pharmaceuticals or Glenmark Pharmaceuticals because they did not reference the ’314 patent in their ANDAs.