A US Federal Court ruled on July 3 that Novopharm USA, a subsidiary ofNovopharm of Canada, could begin selling generic ranitidine hydrochloride, which Glaxo Wellcome of the UK markets as Zantac, on July 10. The ruling mandated that the US Food and Drug Administration give Novopharm its final approval on the drug and reversed its earlier decision to award exclusivity to Genpharm, a subsidiary of the German firm Merck KGaA (Marketletter June 30).
The ruling stated: "Here, neither Geneva (a subsidiary of Novartis of Switzerland - Ed) nor Genpharm, nor any other pharmaceutical company, submitted the first Abbreviated New Drug Application for a generic version of Zantac that included a paragraph IV certification, and successfully defended a suit by GW for patent infringement."
Leslie Dan, chairman and chief executive of Novopharm, said: "it's been the battle of the century for the pharmaceutical industry, and we are thrilled that Novopharm has finally emerged the winner." The firm planned to have its product available in US pharmacies on July 10, as agreed with GW, a full 16 days prior to patent expiration on July 25.
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