Sun Pharma gets US nod to sell generic diabetes drug
13 Jul 2013
Generics specialist Sun Pharmaceutical Industries, India's top drug maker by market value, has received final approval from the US Food & Drug Administration for its Repaglinide tablets used for treatment of diabetes.
The company is eligible for a 180-day marketing exclusivity in the US as its subsidiary Caraco is the first-to-file an abbreviated new drug application (ANDA) for the product with a Para IV certification.
It would be the only company selling the drug in that market other than the innovator Novo Nordisk, which sells it under the Prandin brand.
Novo Nordisk had sued Sun's US subsidiary for patent infringement following the submission of the ANDA for the drug. But on 18 June a US court of appeals ruled in favour of Sun, invalidating the Novo Nordisk's patent.
Sun would sell Repaglinide tablets in the strengths of 1 mg and 2 mg, the company said in a statement.
''These tablets have annual sales of around $200 million in the US. Repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type-2 diabetes mellitus,'' Sun Pharma said.
