Novopharm Gets Green Light For Ranitidine

Ending a six-year battle, a US Federal Court has ruled that the US unit of Canadian company Novopharm may produce a generic version of Form 1 ranitidine (Glaxo Wellcome's antiulcerant Zantac), without infringing the Form 2 patent held for the same drug. Novopharm plans to have its product on the market within 12 months. The patent expiry date for Form 1 ranitidine in the USA is July 1997. The generic version will be priced at between 25% and 40% below the price of GW's product.

While disappointed by the judge's decision, GW believes it has a valid case against Novopharm and that it has strong grounds for appeal to the US Court of Appeals Federal Circuit.

Leslie Dan, Novopharm's chairman and chief executive, said that the ruling by the judge was so strong in his company's favor that he was doubtful an appeal by GW would succeed. Mr Dan added that if GW does appeal, "we will file a $1 billion lawsuit against them."