Financial Daily from THE HINDU group of publications
Saturday, Feb 02, 2002
Financial Daily from THE HINDU group of publications Saturday, Feb 02, 2002 |
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Regulatory Bodies & Rulings Corporate - Announcements Dr Reddy's contests drug ruling in US Our Bureau
HYDERABAD, Feb. 1 CLOSE on the heels of the expiry of 180-day marketing exclusivity for Fluoxetine 40mg capsules in the US generics market, Dr Reddy's Laboratories Ltd has filed a complaint against the United States Food and Drugs Administration (USFDA), seeking marketing exclusivity for Omeprazole 40mg capsules. The company announced on Friday that it filed a case in the US District Court of New Jersey against USFDA seeking reinstatement of its 180-day marketing exclusivity for Omeprazole. The marketing exclusivity for Fluoxetine 40mg capsules expired on January 29, the day the company announced its third-quarter results. Dr Reddy's moved the New Jersey District Court on January 30 challenging the decision of USFDA on Omeprazole. In February 1999, Dr Reddy's filed an abbreviated new drug application (ANDA) with a Paragraph-IV certification with USFDA for Omeprazole delayed-release capsules of 40mg, which is the generic version of AstraZeneca's Prilosec. Following this, AstraZeneca sued Dr Reddy's and other applicants for patent infringement. On May 31 last year, the Southern District Court of New York ruled that one of AstraZeneca's seven patents that was a part of the litigation (Patent no 4,636,499) was not infringed upon by Dr Reddy's. The trial with respect to other patents continued. However, on November 16, USFDA denied Dr Reddy's the grant of marketing exclusivity for Omeprazole 40mg capsules on the grounds that the patent (No 4,255,431), for which Dr Reddy's was the first to file, had expired during the pendency of the suit. USFDA also declared that it was Andrx, which was the first to file with respect to other patents.
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