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India’s largest drug maker, Sun Pharmaceutical Industries, has received final approval from the US Food and Drug Administration (USFDA) to make generic copies of Novartis AG’s blockbuster cancer drug Gleevec.
The generic version of the drug will be launched on February 1, 2016. These tablets have annual sales of about $2.5 billion in the US and are indicated for the treatment of chronic myeloid leukaemia.
The Sun Pharma subsidiary, being the first to file an Abbreviated New Drug Application for generic Gleevec, is eligible for a 180-day marketing exclusivity in the US, giving the company a headstart before other pharma companies also start manufacturing the same drug. Dr Reddy’s Laboratories Ltd has also entered a settlement with Novartis and will launch its drug after Sun Pharma’s drug hits the market.
Big bucks“On a conservative basis, the product can easily contribute sales of around $250-300 million during the six-month exclusivity and a net profit of around $75-90 million during the period. The product can easily enhance the earnings per share of the company in FY2017 by 8-9 per cent,” said Sarabjit Kour Nangra, VP Research, Pharma, at Angel Broking.
In May, Sun Pharmaceutical had inked a settlement with Novartis that led to the dismissal of lawsuits opposing the Indian company’s submissions seeking to sell a generically similar version of Gleevec (Imatinib mesylate) tablets in the US.
The cancer drug comes in 100 mg and 400 mg tablets and currently costs nearly $9,000 for a month’s treatment in the US. The generic is expected to be much cheaper although Sun Pharma did not disclose the pricing.
“It is a big development for Sun Pharma, considering the large market for Gleevec. However, such approvals have now become common place among Indian pharmaceutical companies,” said D Shah, Secretary general of the Indian Pharmaceutical Alliance.
Novartis’ blockbuster drug contributed $4.7 billion in sales last year and was its best-selling drug, according to data compiled by Bloomberg.
The Sun Pharmaceutical stock jumped 6 per cent on the NSE on Friday before closing about 4 per cent up at ₹755.40.
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