BUSINESS
It has first-to-file rights for six major drugs including Lipitor, Nexium, Diovan; opportunity will start opening up from November
After the dark clouds of 2008-09, when it was hammered by the US drugs watchdog, the US market could provide some sunshine for Ranbaxy Laboratories.
If India’s largest pharmaceuticals company by revenue succeeds in timely monetisation of its large opportunities, it could get $1.7 billion (about `7,600 crore) or more.
Ranbaxy has the first-to-file (FTF) status on blockbuster products like Lipitor (cholesterol drug, US revenues $5.5 billion), Nexium (heartburn drug, US revenues $2.7 billion), Diovan (blood pressure drug, US revenues $2 billion), Actos (diabetes medicine, US revenues $1 billion), and these opportunities would start opening up from November 2011.
A FTF status gives the company a six month exclusivity on the products in the US, during which it would be the only company (other than the innovator) to be selling generic versions of the products.
Analysts say timely monetisation of these four opportunities could earn Ranbaxy over $1.7 billion during the exclusivity
period.
Sarabjit Kour Nangra, vice-president, research, Angel Broking, said the company is confident that it would be able to monetise these opportunities as it has done so with products like Aricept, Flomax, Imitrex, Valtrex in the recent past.
“Their growth in the US would mainly come from monetisation of the FTF opportunities,” he added.
A Ranbaxy official said the company cannot comment on product opportunities.
But the company’s Dewas and Paonta Sahib manufacturing plants in Madhya Pradesh and Himachal Pradesh, respectively, which were in the thick of controversy over manufacturing issues, are yet to get cleared by the USFDA (United States Food & Drug Administration).
It is currently manufacturing products at the Ohm facility in the US.
“If they file fresh ANDAs (applications for getting generic drug approvals) from a new facility, it will take time to get approvals. If a facility like Ohm is involved, the cost of production will be more than it is in India,” says Ranjit Kapadia, vice president, institutional research, HDFC Securities.
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