MYLAN HAS FIRST GENERIC VERSION OF BOEHRINGER-INGELHEIM's COMBIPRES

Executive Summary

MYLAN HAS FIRST GENERIC VERSION OF BOEHRINGER-INGELHEIM's COMBIPRES (clonidine/chlorthalidone); the generic company began marketing the combination product during the week following ANDA approval of the drug on Feb. 9. Mylan estimated the current market for the brandname drug at approximately $17-18 mil. annually, based on IMS data. Mylan is marketing the generic at an average wholesale price of $23.35 for 100 capsules of .1 mg clonidine/15 mg chlorthalidone; $31.20 for 100 capsules of .2 mg clonidine/15 mg chlorthalidone; and $37.70 for 100 capsules of .3 mg clonidine/15 mg chlorthalidone. Generic versions of clonidine (Boehringer-Ingelheim's Catapres) have been available since July 1986, when the patent on Catapres expired. Mylan indicated that it has plans to market generic clonidine as well. In 1986, Mylan received first generic approvals for five products. Of those, the firm received a same day approval for haloperidol with Searle (June 10) and with Barr for chlordiazepoxide/amitriptyline HCl (Dec. 10). Mylan's remaining first approvals in 1986 were for doxepin HCl, meclofenamate sodium, and tolazamide. Mylan had four first approvals in 1985.