Merck Generics Affiliate Genpharm Receives FDA Tentative Approval For Omeprazole
Merck KGaA today announced that its Canadian generics affiliate Genpharm Inc., headquartered in Toronto, Canada, on October 18, 2002, received FDA 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 Genparm'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 generic market co-exclusivity for both its 10 mg and 20 mg omeprazole capsules. "Obtaining tentative approval removes the last regulatoy hurdles for Genpharm's products" says Hank Klakurka, CEO of Genpharm. "We are obviously very pleased that after awarding Genpharm co-exclusitiy the FDA has now found the Genpharm products to be safe and effective".
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