CRESTOR ANDA
On 30th October 2007, AstraZeneca received a notice-letter from Cobalt Pharmaceuticals, Inc. (“Cobaltâ€) notifying AstraZeneca Pharmaceuticals LP, AstraZeneca AB, IPR Pharmaceuticals Inc., and Shionogi Seiyaku Kabushiki Kaisha that Cobalt had submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration for approval to market generic rosuvastatin calcium tablets. Cobalt’s notice-letter advised that it intended to market generic versions of Crestorâ„¢ tablets in 5, 10, 20, and 40 mg strengths before the expiration of US Patents Nos. RE37,314E (the ‘314 patent) and 6,316,460B1 (the ‘460 patent). Cobalt’s notice-letter states that its ANDA contained a Paragraph IV certification alleging that the claims of the ‘314 and ‘460 patents are not infringed, invalid or unenforceable. Cobalt’s notice-letter also states that its ANDA contains a certification under section 505(j)(2)(A)(viii) of the FDCA alleging that its labelling will not include medical uses claimed in US Patent 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.
AstraZeneca is evaluating Cobalt’s allegations and certifications. AstraZeneca has full confidence in its intellectual property portfolio protecting Crestor™.
AstraZeneca has 45 days within which to commence a patent infringement lawsuit against the filer of an ANDA that would automatically stay, or bar, the FDA from approving the ANDA for 30 months (or until an adverse court decision, whichever may occur earlier).