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Alzheimer generic launched in the US Posted 28/08/2015

Indian generics giant Dr Reddy’s Laboratories announced on 13 July 2015 the launch of generic memantine hydrochloride tablets in dosages of 5 and 10 mg, following approval of the company’s abbreviated new drug application (ANDA) by the US Food and Drug Administration (FDA).

The drug is a generic version of Forest Laboratories blockbuster Alzheimer’s disease treatment Namenda (memantine). Namenda had US sales of approximately US$1.4 billion for the twelve months ending May 2015, according to IMS Health.

Actavis, and its subsidiary Forest Laboratories, have already been surrounded by controversy after the companies were forced to continue selling the immediate-release version of Namenda by New York’s attorney general Eric Schneiderman [1]. The companies had planned to discontinue the immediate-release version of the Alzheimer’s drug (Namenda IR) and switch patients to an extended-release version (Namenda XR). The US patent on Namenda IR expired in January 2015, while the patent on the newer version expires in 2025.

Forest Laboratories has also filed a lawsuit against generics makers Sun Pharma Global, Teva Pharmaceuticals USA and Wockhardt Bio, all of whom have filed ANDAs with FDA seeking approval to market generics of Namenda XR [2].

Related article
Generics applications under review by EMA – 2013 Q4

References
1. GaBI Online - Generics and Biosimilars Initiative. Actavis agrees to continue making Alzheimer’s drug for now [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 28]. Available from: www.gabionline.net/Generics/News/Actavis-agrees-to-continue-making-Alzheimer-s-drug-for-now
2. GaBI Online - Generics and Biosimilars Initiative. Forest Labs files lawsuit to stop generic memantine [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 28]. Available from: www.gabionline.net/Generics/News/Forest-Labs-files-lawsuit-to-stop-generic-memantine

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Source: Dr Reddy’s

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