Ciba Postpones Generic Captopril Introduction

Ciba has postponed the introduction of its generic version of Bristol-Myers Squibb's ACE inhibitor captopril until February, as part of an agreement reached between the two firms. Terms of the agreement have not been divulged.

Ciba's Geneva unit received approval for its Abbreviated New Drug Application on November 9, and was the first company to do so because B-MS failed to file suit against the company under the 45-day waiting period under the Waxman-Hatch Act.

Paragraph IV of this act calls for a generics firm to inform the originator company when it has amended its ANDA to state that its product either does not infringe the patent on the original product, or that the patent is invalid. After this, the originator has the option to file suit against the generics firm, which automatically puts the approval on hold.