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Dr. Reddy: Generic potential

Jun 4, 2001

The recent decision of a US court of appeals in favour of Barr Labs for launch of fluoxetine 10 mg / 20 mg (generic Prozac, an blockbuster anti-depressant drug) has come as a blessing in disguise for Dr. Reddy’s. The decision thus invalidates the patent protection to Eli Lilly, the original patent holder, that would have prevented any generic competition for the drug prior to December 2003. While Barr case was for 10 mg / 20 mg exclusivity, Dr. Reddy’s has a similar case (for the same drug) for 40 mg dosage. With the decision for 10 mg / 20 mg dosage now in favour of the Barr, one can expect a similar decision for 180 days generic exclusivity in favour of Dr. Reddy’s. The potential for Dr. Reddy’s is huge given that the annual branded sales for fluoxetine are in the range of US $ 275 m . Further, the court case for marketing generic version of prilosec (generic Omeprazole) has also inched in favour of Dr. Reddy’s. Prilosec, (another blockbuster product for gastro-intestinal disorders) has estimated sales of more than US$ 4 bn. Dr. Reddy's is expecting to get ‘first to file’ status and consequently, 180 days exclusivity for 40 mg version of omeprazole, and also plans to market other versions once the exclusivity period for those versions is over.

Both the developments further strengthens Dr. Reddy’s thrust to expand into high margin US generics market. It may be recalled that the company notched up maiden sales of US$ 6.5 m during its first four months of operations (December to march 2001), successfully gaining strong market share in recent launches (Famotidine and Oxaprozin). The company has forged alliances with top-tier companies (Par, Leiner Healthcare, Warrick) to ensure timely launches for its pipeline products through co-marketing and rapidly acquiring a critical mass in the US generic market.

Dr. Reddy currently has 28 Abbreviated New Drug Application (ANDA) filings to its credit. The company plans to file 11 new ANDAs in the US in the current year. Together, all ANDA filings of the company should sustain a strong revenue momentum from the generics markets in the next 2-3 years. It is expected that the company can notch up revenues of close to US$ 45 m from its US generic operations, if it is able to bag the 180 days marketing exclusivity for fluoxetine.

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