IVAX' GENERIC SUSTAINED-RELEASE VERAPAMIL LAUNCHED AT NEAR 25% DISCOUNT
Executive Summary
IVAX' GENERIC SUSTAINED-RELEASE VERAPAMIL LAUNCHED AT NEAR 25% DISCOUNT to Searle's Calan SR and Knoll's Isoptin SR. Ivax subsidiary Baker Norton began shipments on Aug. 18 following approval by FDA on July 31 ("The Pink Sheet" Aug. 10, p. 6) and FDA validation of the company's production process. The Baker Norton verapamil product carries an "AB" bioequivalence rating to Calan SR and Isoptin SR, but not Lederle/Wyeth-Ayerst's sustained- release verapamil product, Verelan. Trade sources say Baker Norton is offering its generic extended-release verapamil 240 mg (bottles of 100 tablets) at a direct price to wholesalers of $72.50. Searle and Knoll reportedly price their respective once-a-day 240 mg verapamil products direct to wholesalers at $95.43 per bottle of 100s. The two brands are listed in the RedBook by AWP only -- $114.52 per bottle of 100s. The generic sustained-release verapamil product will be marketed by Ivax' generic drug distribution subsidiary, Goldline Labs, which was acquired last December for $63 mil. in stock ("The Pink Sheet" Jan. 6, T&G-5). The new Goldline generic will be entering a sustained-release verapamil market in excess of $500 mil. Searle has requested a meeting with FDA, scheduled for Aug. 26, to discuss a citizen's petition the company filed on Aug. 5 that seeks to prevent an "AB" bioequivalence designation for the Ivax product by the agency. Searle is arguing that the bio studies conducted by Ivax were insufficient to prove bioequivalence given the chemical structure of racemic verapamil, which is comprised of two stereoisomers. FDA, however, already has given the Ivax product an "AB" rating, which will be included in an upcoming supplement to the agency's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the "Orange Book." Nonetheless, FDA is understood to be interested in pursuing Searle's request to bring the subject of stereoisomer bioequivalence testing before the Generic Drugs Advisory Committee at an upcoming meeting.