Dr Reddy's Laboratories has received tentative approval from the US Food and Drugs Administration for generic Nesazodine HCL tablets with dosage strengths of 50 mg, 100 mg, 150 mg, 200 mg and 250 mg.
Nesazodine is the generic variant of Bristol Myers Squibb's (BMS) anti-depressant drug Serzone.
In addition to Dr Reddy's Labs, seven other companies have also received tentative approvals for the drug, which recorded a sales of $261 million in US in 2002 as per IMS data.
Of the two patents that BMS has got for the drug, the pediatric exclusivity of the first patent will expire on September 16, 2003, while the second patent will expire only in 2012.
Though it will be one more addition to Dr Reddy's generic portfolio in US market in the near future, the product is unlikely to contribute any major revenues for the company in view of the presence of several players and a limited market size.
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