Ives, Leo/Roche, Sterling patent extension requests

Executive Summary

Ives seeking two-year extension to Dec. 31, 1993 for Sectral (acebutolol HCl) caps, which would give the antihypertensive a nine-year monopoly; Leo/Roche requesting two-year extension to May 18, 1995 for Coactin (amdinocillin), to provide 10-1/2 years of patented marketing of the injectable antibiotic; Sterling seeking two-year extension for Tornalate (bitolterol mesylate), to give the metered-dose bronchodilator inhaler a 13-year monopoly. Three applications fall under the patent extension law's provision limiting extensions to two years for drugs whose clinicals began before enactment but were approved after enactment; FDA cleared the drugs in late December.