Genpharm Gets Exclusivity For Generic Zantac In USA

A mood of uncertainty followed the news that Genpharm of Canada, a unitof the German group Merck KGaA, had received from the US Food and Drug Administration a temporary registration to market a generic version of Glaxo Wellcome's antiulcerant Zantac (ranitidine HCl).

The FDA go-ahead amounts to an exclusivity period of 180 days from March 3 to August 29 for Genpharm. This has caught out other generic companies planning to market generic ranitidine, such as Novartis' unit Geneva Pharmaceuticals, and another Canadian company, Novopharm, the latter having struck up a deal with Glaxo Wellcome in April to market its version of generic Form 1 ranitidine before the US patent expires on July 25 (Marketletter May 5).

Speaking to the Marketletter, Novopharm emphasized that the US Food and Drug Administration has not given Genpharm final approval to market its version of ranitidine.