Natco files ANDA for generic cancer drug

Drug maker Natco Pharma today said it has sought the US health regulator's nod to sell lenalidomide capsules, used in treating cancer, in the American market.

The company has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration to market lenalidomide capsules prior to the expiry of various US patents, Natco Pharma said in a filing to the Bombay Stock Exchange (BSE).

The company has sought the approval to sell lenalidomide capsules in strengths of 5, 10, 15 and 25 mg, it said.

"Natco believes it may be the first applicant to file an ANDA for the 25 mg generic version and is hoping for 180 days of marketing exclusivity," the company added.

Lenalidomide capsules are generic version of Celgene Corporation's Revlimid used in the treatment of multiple myeloma (cancer of plasma cells in bone marrow), which has also shown efficacy in treating bone marrow stem cell disorders.

"The market size of Revlimid is estimated to be around $1.5 billion and has grown by 44 per cent from last year", the company said in a statement.

The shares of Natco today closed at Rs 251.10 per piece on the BSE, down 5.30 per cent from its previous close.