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Caraco Pharma, US subsidiary of Sun Pharmaceuticals has received final approval for its for generic version of Prandin (Repaglinide tablets). Repaglinide tablets, 1 mg and 2 mg are therapeutic equivalents of Novo Nordisk’s Prandin tablets.
Following the announcement, Sun's shares touched an all-time high of Rs 1,112 on BSE. Shares were closed at Rs 1,108, up by 1.2% on Friday.
These tablets have annual sales of approximately $200 million in the US. According to analysts, Sun Pharma is expected to generate about $30 mlllion revenue during exclusivity period.
Repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. Caraco, being the first-to-file an ANDA for generic Prandin with a para IV certification, is eligible for a 180-day marketing exclusivity in the US.
Earlier in 2005, Caraco had filed repaglinide ANDA under Para IV. In 2011, the metformin combination (expiring in June 2018) was successfully invalidated in the District Court which further was appealed in US Court of Appeal for Federal Circuit.
On June 20, 2013 Federal Circuit has made the verdict allowing Caraco to market generic Prandin in the US.
