Ranitidine OTC Private Labels Ready For January Launch
This article was originally published in The Tan Sheet
Executive Summary
At least three private label marketers will launch OTC 75 mg ranitidine immediately upon termination of Novopharm's 180-day marketing exclusivity Jan. 19. Perrigo, PL Developments and Zenith Goldline Pharmaceuticals showcased their versions of the H2 antagonist at the Private Label Manufacturers Association annual trade show in Chicago Nov. 14-16.
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Leiner Health Products
Company to purchase "substantially all of the assets" of Novopharm's Granutec and Stanley Pharmaceuticals divisions under a definitive agreement announced Oct. 25; the transaction is expected to be completed prior to year-end. Both Leiner and Granutec sell private label cimetidine (SmithKline's Tagamet HB). Granutec also began shipping generic ranitidine July 19, a month after Warner-Lambert's Zantac 75 lost its exclusivity. Stanley Pharmaceuticals manufactures and distributes OTCs and vitamin supplements in Canada; Novopharm is based in Toronto
Private label ranitidine
The H2 antagonist has begun reaching shelves at drug chains and wholesalers, mass merchandisers, food chains and warehouse clubs nationwide, Toronto, Canada-based Novopharm says. The product began shipping July 19. Novopharm says its subsidiary, Granutec, has shipped over 170 mil. tablets "to meet anticipated consumer demand for the lower cost generic." Warner-Lambert lost marketing exclusivity for the reference drug, Zantac 75, June 19. FDA granted Novopharm 180 days of marketing exclusivity for the private label version that is set to expire Jan. 19; the decision was challenged by Apotex but upheld by a D.C. federal court June 15 (1"The Tan Sheet" June 21, p. 3)
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