Dr Reddy's Laboratories Limited on Monday announced the launch of Imatinib Mesylate tablets, a generic version of Novartis' blockbuster anti-cancer drug Gleevec, in the US market.
The drug is used in treating chronic myeloid leukaemia.
The company has received US Food and Drug Administration (USFDA) approval to manufacture and market the product.
Gleevec and its generic equivalents saw sales of approximately $868 million in the US for the last twelve months ending in July 2018, the company said quoting the IMS Health statistics. In a recent report, IIFL said it was forecasting $34 million of revenues from the sale of Imatinib Mesylate in Dr Reddy's top-line in the current financial year and $60 million in 2019-20.
Sun Pharma was the first Indian company to receive the US FDA approval for generic Imatinib Mesylate tablets. It was also given the first-to-file status carrying 180-day exclusivity in 2015 when the soon to be off-patent Gleevec saw sales of around $2.5 billion in the US market.
Sun Pharma launched the generic Gleevec in the following year, while other major Indian companies such as Dr Reddy's were yet to receive the approval for their generic versions.
Dr Reddy's had to wait a little longer for the product approval even as increased competition and entry of multiple generic versions have driven down the price of Imatinib Mesylate. Yet, the product holds promise for the company, according to analysts.
Apart from Imatinib Mesylate, over-the-counter generic Nexium, which has a market of little over $300 million in the US, too was one of the significant products recently launched by Dr Reddy's. The company hopes to launch over 15 products in the US in the current year.
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