United Research Laboratories/Mutual Pharmaceutical Co

Drug Store News, April 19, 2004

United Research Laboratories/Mutual Pharmaceutical Co. received tentative FDA approval for its ANDA for felodipine 2.5 mg, 5 mg and 10 mg extended-release tablets, the generic version of AstraZeneca's Plendil ER, a vasoselective calcium antagonist for treating hypertension and angina pectoris. According to URL/Mutual, it was the first to file an ANDA, entitling it to a 180-day market exclusivity period upon successful resolution of existing patent litigation and final FDA approval.

URL/Mutual's ongoing Paragraph IV litigation in respect to AstraZeneca's patent for the drug is under appeal. Plendil generated 2003 sales of more than $240 million.