Friday was a red letter day for the Hyderabad-based Dr Reddy's Laboratories in particular and the Indian pharmaceuticals industry in general.
Dr Reddy's has become the first Indian company to get a 180-day market exclusivity from the American authorities for its generic dosage form of a patented drug, which has gone off patent on August 2.
Following the receipt of final approval from the United States Food and Drug Administration (US FDA) to market its fluoxetine 40 mg capsules on August 2, 2001, Dr Reddy's formally launched the product through its alliance partner, Pharmaceutical Resources Inc, in the US today.
Fluoxetine is a blockbuster anti-depressant invented by Eli Lilly & Co. Dr Reddy's, in a press release today, said that it had received the 180-day market exclusivity for fluoxetine 40 mg capsules effective from July 27, but could not launch the product until the expiry of six-month paediatric exclusivity of the original inventor, Eli Lilly & Co's Prozac (the brand name for fluoxetine) on August 2.
Dr Reddy's alliance partner, Pharmaceutical Resources Inc, has also received the 180-day market exclusivity for its fluoxetine 10 mg and 20 mg tablets.
Dr Reddy's claimed that it along with Pharmaceutical Resources would be the only entity to market the entire range of dosage strengths of fluoxetine (10 mg tablets, 20 mg tablets and 40 mg capsules) during the marketing exclusivity period.
The launch of fluoxetine generic by Dr Reddy's became almost certain on July 27 when a final judgement was issued by the Indiana, US, district court dismissing the case pertaining to Prozac filed by Eli Lilly & Co against Barr Laboratories Inc, Dr Reddy's and some other companies.
Dr Reddy's further stated that it believed to be the first company to file status on omeprazole 40 mg capsules, ciprofloxacin 100 mg and 750 mg tables, and olanzapine 20 mg tablets.
All these drugs are still covered by patents. Omeprazole is likely to come out of patent by October 2001.
Basic patent for ciprofloxacin is valid till December 2003 while the same will expire in late 2003 or early 2004 for olanzapine.
