PHARMACEUTICAL BASICS' TIMOLOL MALEATE IS FIRST ANDA APPROVAL

Executive Summary

PHARMACEUTICAL BASICS' TIMOLOL MALEATE IS FIRST ANDA APPROVAL for a generic version of Merck's beta blocker Blocadren. The Pharmaceutical Basics Inc. (PBI) timolol ANDA was approved in 5 mg, 10 mg and 20 mg strengths on Jan. 10. The approval is effectively delayed until April 11, when Merck's patent for timolol expires. The timolol patent is also the effective patent for Merck's ophthalmic product Timoptic, which controls a much larger market than the heart drug Blocadren. Analyst estimates for Timoptic sales in the U.S. are in the $100-110 mil. range, while Blocadren sales are estimated in the $15-20 mil. range. On Jan. 11, FDA approved Danbury's ANDA for prazosin - the second generic version of Pfizer's Minipress (prazosin). Zenith received an ANDA approval for prazosin in September. Marketing of prazosin is delayed until May 16, 1989, according to FDA's "Orange Book."