Favorable Ruling by United States Supreme Court on Prandin Litigation
Landmark decision for generic companies
MUMBAI, India, April 18, 2012 /PRNewswire/ --Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) announced that the United States Supreme Court has ruled in favour of its subsidiary Caraco Pharmaceutical Laboratories, Ltd. in its' patent litigation against Novo Nordisk over Caraco's generic version of Prandin®, Repaglinide Tablets.
The Supreme Court, in a unanimous opinion, concluded that Caraco can seek correction of Novo Nordisk's inaccurate use code regarding the combination use of repaglinide and metformin for the treatment of type 2 diabetes. Sun Pharma is pleased that this landmark decision will help all generic companies prevent brand companies from improperly delaying or preventing the marketing of generic drugs against their products by misrepresenting their patents to the USFDA.
Caraco's ANDA for generic Prandin® is still awaiting approval at the USFDA. Also, a separate appeal concerning the validity of patents for Prandin® is currently pending before the Court of Appeals for the Federal Circuit after a lower court ruled in favour of Caraco. Prandin® has annual sales of approximately $230 million in the US.
Prandin® is a registered trademark of Novo Nordisk.
About Sun Pharma
Established in 1983, listed since 1994 and headquartered in India, Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) is an international, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world. In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, orthopedics and ophthalmology. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms. More information about the company can be found at http://www.sunpharma.com.
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SOURCE Sun Pharmaceutical Industries Ltd.
Posted: April 2012
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