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Pravachol judicial windfall

Executive Summary

Bristol-Myers Squibb netted an estimated $13.4 mil. from the four-day delay of generic pravastatin market entry, based on average Pravachol sales during the first quarter of $3.35 mil. per day in the U.S. Bristol's compound patent expired April 20, and FDA delays approval of Teva's 10 mg, 20 mg and 40 mg pravastatin ANDAs until April 24. The delay resulted from an April 20 D.C. Circuit Court of Appeals ruling enjoining FDA from approving pravastatin ANDAs until the court had time to review a motion for injunctive relief from Apotex. Bristol was not a party to the case. Ranbaxy, which holds 180-day exclusivity rights for the 80 mg dose, still awaits FDA approval[Editor's note: In-depth coverage of Pravachol legal proceedings appeared in 1"The Pink Sheet" DAILYApril 25. To read the article and sign up for a free trial, visit our website,]...

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