July 12, 2013 / 3:00 AM / in 5 years

India's Sun Pharma gets FDA approval for diabetes generic drug

July 12 (Reuters) - India’s Sun Pharmaceutical Industries said on Friday it has received final approval from the United States Food and Drug Administration (FDA) to launch the generic version of Novo Nordisk’s Prandin diabetes drug.

Prandin, known chemically as repaglinide, and its combination with the commonly prescribed type 2 diabetes drug metformin, sold as PrandiMet, had sales of about $200 million in 2012 for Novo.

Sun Pharma said it would be eligible for a 180-day marketing exclusivity in the United States for the drug.

A U.S. appeals court last month found the patent on Novo’s Prandin diabetes drug in combination with metformin to be invalid, paving the way for the introduction of a generic version of the drug.

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