The FDA has granted the Genpharm Inc tentative approval to market its 10 mg and 20 mg omeprazole capsules that are generic versions of AstraZeneca's ulcer drug Prilosec. The FDA has stated that Genpharm was granted tentative approval because its omeprazole drug products are safe and effective for their labeled uses, and based on Genpharm's right to appeal a recent federal district court decision in which two of AstraZeneca's patents concerning Prilosec were found valid and infringed by Genpharm. In that decision, four other Prilosec patents were held invalid or not infringed by Genpharm, based on evidence presented by Genpharm.
According to the FDA, if Genpharm prevails on appeal as to the two patents found to be infringed, it will be given a final approval. Previously, on November 16, 2001, the FDA had awarded Genpharm 180 days co-generic market exclusivity for both its 10 mg and 20 mg omeprazole capsules. "Obtaining tentative approval removes the last regulatory hurdles for Genpharm's products," says Hank Klakurka, C.E.O. of Genpharm. "We are obviously very pleased that after awarding Genpharm co-exclusivity, the FDA has now found the Genpharm product to be safe and effective."
Genpharm Inc is an affiliate of the Merck Generics Group, a corporate division of Merck KGaA of Germany. Genpharm is engaged in the development, manufacturing and marketing of high quality, cost effective prescription pharmaceuticals around the world in conjunction with the Merck Generics global group of companies.