FDA NOD TO RANBAXY FOR GSK DRUG CLONE

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RANBAXY Laboratories has received marketing approval to sell the low-cost version of GlaxoSmithKline’s (GSK) anti-migrane drug, Imitrex (Sumatriptan), in 100-mg dosage in the US with 180-day marketing exclusivity. The company had earlier missed its December 2008 launch date as it did not get approval from the US drug regulator.

As per industry estimates, the 100 mg dosage accounts for about 60-65% of Imitrex’s total sales in the US. This means, Ranbaxy can potentially earn $25-30 million during the 180-day exclusive marketing period when it will face no competition from similar low-cost generic drugs.

When contacted, a Ranbaxy spokesman said:”We have received the US Food and Drug Administration’s (USFDA) approval for 100-mg Sumatriptan.” A person close to the development said the company received the marketing approval from its Ohm facility in the US.

In January 2008, Ranbaxy had announced that it has reached an out-of-court settlement with GlaxoSmithKline (GSK) that allowed the Indian company to launch the generic version of Imitrex in the US with 180-day marketing exclusivity. But, following the ban on two of its manufacturing facilities in India from where it proposed to make the drug, it did not receive USFDA’s approval, and missed the launch date.

Ranbaxy will now make the drug in its US facility and has applied for a new marketing permission there. As per a Citigroup report, Ranbaxy sources its active pharmaceutical ingredient (API) or the basic chemical to make Imitrex from Hyderabad-based SMS Pharma.

The USFDA approval is also significant given the stormy relations between Ranbaxy and the US drug regulator. Despite the delay, the company has managed to retain the 180-day exclusivity period.

The approval could also boost the company’s quarterly sales figures for the next two quarters. The company posted its second consecutive quarterly loss due to foreign exchange loss and ban on 30 drugs in the US. The FDA had banned the import of 30 drugs from Ranbaxy’s two Indian facilities. FDA is also investigating Ranbaxy for allegedly manufacturing sub-standard drugs and data fraud. The company has denied any wrongdoing.

Ranbaxy’s gain will also marginally hurt Dr Reddy’s Laboratories (DRL) in the US. DRL witnessed a 49% growth in revenues driven by sales of its authorised generic versions of Imitrex in 25 mg, 50 mg and 100 mg doses. The drug contributed to more than half to the company’s top line increase.

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