Cobalt challenges Crestor patent
Anglo-Swedish drug major AstraZeneca has revealed the receipt of a "notice letter" from USA-based Cobalt Pharmaceuticals, aimed at itself and Japan's Shionogi, advising the firms that it had submitted an Abbreviated New Drug Application to the US Food and Drug Administration to market a generic version of their blockbuster cholesterol-lowerer Crestor (rosuvastatin), before the expiration of US patents numbers RE37,314E (due to expire in August 2020) and 6,316,460B1 (which has an expiry date of December 2021).
Cobalt has said that its ANDA contains a certification alleging that its labeling will not include medical uses claimed under the '618 patent. The UK-based company says it is evaluating Cobalt's allegations and certification but stresses that it has "full confidence" in its intellectual property portfolio protecting the drug.
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