Skip to Content

Crestor ANDA

LONDON, Nov. 1, 2007-On 30th October 2007, AstraZeneca received a notice-letter from Cobalt Pharmaceuticals, Inc. (“Cobalt”) 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 Crestor™ 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).

Media Enquiries:
Steve Brown, +44 207 304 5033 (24 hours)
Edel McCaffrey, +44 207 304 5034 (24 hours)

Investor Enquiries:
Jonathan Hunt, +44 207 304 5087
Ed Seage, +1 302 886 4065
Karl Hard, +44 207 304 5322
Jorgen Winroth, +1 212 579 0506
Mina Blair, +44 20 7304 5084
Peter Vozzo, (MedImmune) +1 301 398 4358

Posted: November 2007