Dr Reddy's Laboratories has received tentative approval from the US Food and Drug Administration for its Nesazodone HCL tablets which is a generic version of Bristol-Myers Squibb's (BMS) anti-depressant drug, Serzone. DRL got the approval of the US agency to market the drug in dosages of 50mg, 100mg, 150mg, 200mg and 250mg. Serzone had sales of $261 million in the US in 2002, according to a spokesman of the company.
BMS has got two patents for the drug and the paediatric exclusivity for the first patent will expire on September 16, 2003, while the second patent will expire only in 2012.
Besides Dr Reddy's Labs, seven other companies have also received tentative approvals for the drug. Earlier, Ranbaxy Laboratories had received tentative approvals for the same dosages of the drug in April this year.
Since there are several players and the drug has a limited market, the entry of Nesazodone is unlikely to contribute any major revenue for the company. However, with one more addition to Dr Reddy's generic portfolio, the company would establish a firm foothold in the highly competitive US market. The company has more than 10 US FDA approvals so far. Twenty-three ANDAs are pending which account for a market share of $ 13 billion, the company's spokesman said.
According to the source, the hearing in DRL's case relating to Amlodipine Maleate against the US multinational Pfizer has begun. The company has got two products in the speciality pipeline and one of them is Amlodipine Maleate.