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AZ sues over Crestor patent

AstraZeneca has filed suit against Watson Pharmaceuticals to block a generic version of blockbuster cholesterol medication Crestor

AstraZeneca (AZ) has filed a suit against Watson Pharmaceuticals in an effort to block the company from launching a generic version of the blockbuster cholesterol medication Crestor before the drug's patent protection expires in 2016.

The suit was filed after Watson submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval to market rosuvastatin zinc 5, 10, 20 and 40mg tablets, which are a new salt version of AZ's Crestor tablets.

The filing of the suit means there is a stay of final FDA approval of Watson's NDA until March 30, 2013 or until the court makes a decision in the legal action, whichever comes first. The lawsuit was filed under the provisions of the Hatch-Waxman Act, which grant a 30-month stay when patent litigation ensues over a generic marketing application.

Crestor is indicated as an adjunct to diet to lower low-density lipoprotein (LDL) cholesterol, raise high-density lipoprotein (HDL) cholesterol, and slow the progression of atherosclerosis. For the 12 months ended June 30, 2010, the drug had US sales of about $3.5bn, making it one of AZ's top-selling products.

Earlier this year, AZ won a court battle against generics firms including Teva Pharmaceutical when a US District Judge in Wilmington, Delaware ruled that the companies' challenges to the Crestor patent were invalid. The companies had charged that AZ didn't fully disclose certain key information its application to US Patent and Trademark Office, but the judge determined that there was no intent to deceive.

AZ has published its Q3 2010 financial results, which show a drop in profits due, in part, to generic competition. 

28th October 2010

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