Sun Pharmaceutical subsidiary granted USFDA approval for generic Namenda tablets

May 7 2010

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.