US-based Abbott Laboratories has sued Sun Pharmaceutical Industries and Ranbaxy Laboratories in courts there for challenging the patents of its cholesterol-lowering drugs, Niaspan and TriCor, respectively, in separate infringement suits.
A suit filed on June 4 in the district court of Delaware against Sun Pharma and its UAE-based subsidiary, Sun FZE, was in response to an abbreviated new drug application filed by Sun with the US Food and Drug Administration for approval to market the generic versions of 750-mg niacin extended-release tablets. Abbott sells the drug in 500 mg, 750 mg and 1,000 mg forms.
Niacin extended-release tablets are used to raise HDL (good) cholesterol and lowers LDL (bad) cholesterol and triglycerides in people with abnormal levels.
Such patent litigation is common in the US, as an innovator company has to sue a generic maker which challenges the patent of a drug with a Para IV certification within 45 days of intimation. Such suits seek to bar the US FDA from giving approval for the drug for the next 30 months.
Sun's application challenged two patents of the drug, issued in June 2000 and October 2002, said the complaint from Abbott and its arm, Abbott Respiratory. Abbott had earlier filed patent infringement suits against Sun