Sun Pharma announces USFDA approval for generic Namenda® tablets
MUMBAI, India--(BUSINESS WIRE)--Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Forest Laboratories, Inc.'s Namenda 5 mg and 10 mg tablets.
Sun was amongst the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification to the ‘703 patent. Sun's subsidiary is eligible for 180 days generic exclusivity.
These generic Memantine tablets are equivalent to Forest Laboratories, Inc's Namenda® tablets and include two strengths: 5 mg and 10 mg. These strengths of Memantine have a combined annual sale of approximately $1.2 billion in the US.
Memantine tablets are indicated for the treatment of moderate to severe Alzheimer's Disease.
Namenda ® is a registered trademark of Forest Laboratories, Inc.
Licensed from Merz Pharmaceuticals GMBH.
About Sun Pharmaceutical Industries Ltd.
Established in 1983, listed since 1994 and headquartered in India, Sun Pharmaceutical Industries Ltd. (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, and orthopedics. 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 www.sunpharma.com.
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