Capoten exclusivity ends: Geneva generic shipments begin Nov. 10.
Executive Summary
CIBA/GENEVA BEGINS GENERIC CAPTOPRIL SHIPMENTS NOV. 10 following FDA approval of an ANDA for a version of Bristol-Myers Squibb's Capoten on Nov. 9. Geneva became the first outside company with a fully-approved ANDA for the ACE inhibitor when Bristol did not file suit against the company during the 45-day waiting period established under Waxman/Hatch for ANDAs with paragraph IV certifications.