Cobalt Eyes AstraZeneca’s Blockbuster Cholesterol Drug

In a major development, the Canadian drug manufacturer Cobalt Pharmaceuticals stunned AstraZeneca by making Paragraph IV certification against Astra’s money-spinning cholesterol drug Crestor which worth US $ 2 billion in a process for submission of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking regulatory approval to market generic version of Crestor, generically known as rosuvastatin calcium, before the expiration of Astra’s Orange Book listed patents valid till 2021. AstraZeneca has 45-day statutory period under the Hatch-Waxman provision for deciding to initiate an infringement action and halting FDA from approving the generic version for at least 30 months. AstraZeneca has three patents listed with the Orange Book including composition-of-matter patent. In its notice to Astra, Cobalt intended market generic version of Crestor before the expiration of US Patent Nos. RE 37, 314 (the ‘314 patent) and 6,316,460 (the ‘460 patent) alleging that the claims of the ‘314 and ‘460 patents are not infringed, invalid or unenforceable. Also stated that its ANDA contains a certification under section 505(j)(2)(A)(viii) of the FDCA alleging that its labeling will not include medical uses claimed in the US Patent No. 6,858,618 (the ‘618 patent). The ‘314 patent expires in January 2016, the ‘460 patent expires in August 2020, and the ‘618 patent expires in December 2021.