WILMINGTON, Del. The U.S. District Court for the District of Delaware has upheld the patent on a cardiovascular drug made by AstraZeneca, the Anglo-Swedish drug maker said Tuesday.
Judge Joseph Farnan ruled that the substance patent covering the drug Crestor (rosuvastatin calcium), U.S. Patent No. RE37,314, is valid and enforceable. The decision was in response to several companies’ attempts to market generic versions of the drug, including Mylan, Teva Pharmaceutical Industries and Apotex. The decision bars the Food and Drug Administration from approving a generic version of Crestor before the ’314 patent’s expiration, in 2016.
One of the most abbreviated new drug applications filed with the FDA was from India-based generic drug maker, Glenmark Generics. The company was seeking approval for the commercial manufacture, use, importation, offer for sale and sale of rosuvastatin calcium (the active ingredient in Crestor) tablets in 5 mg, 10 mg, 20 mg and 40 mg dosage strengths.
“We are pleased with the court’s decision upholding the validity and enforceability of the ’314 substance patent,” AstraZeneca CEO David Brennan said. “The court’s decision reaffirms the strength of the intellectual property protecting Crestor.”