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Allergan makes deal with Amneal over its Namenda XR generic Posted 09/10/2015

Allergan has gained some breathing space for the extended-release version of its blockbuster Alzheimer’s disease treatment Namenda XR (memantine XR) after making a deal to delay generics entry for more than four years.

Allergan announced on 10 September 2015 that its subsidiary Forest Laboratories (Forest) had made a deal with US generics maker Amneal Pharmaceuticals (Amneal) regarding the latter’s generic version of the drug. The deal comes after Forest, along with Merz Pharma (Merz) and Adamas Pharmaceuticals (Adamas), initiated patent litigation in response to Amneal’s abbreviated new drug application (ANDA) seeking approval to market generic extended-release memantine [1].

Amneal is believed to be the first applicant to file an ANDA containing a paragraph IV certification regarding Namenda XR, which would give Amneal 180-days marketing exclusivity. The deal means that Amneal can start marketing its generic version from 31 January 2020, following approval of its ANDA by the US Food and Drug Administration (FDA). Alternatively, Amneal can wait until 31 January 2021 and launch an authorized generic drug.

The US patent on the immediate-release version of Namenda (Namenda IR) expired in January 2015. Generics giant Dr Reddy’s Laboratories launched its generic of memantine in July 2015 [2], which was closely followed by a number of other generics makers.

The patent on the newer extended-release version of Namenda (Namenda XR) only expires in 2025. However, this is not the end of the story. 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 [3].

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Actavis agrees to continue making Alzheimer’s drug for now

References
1.   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 Oct 9]. Available from: www.gabionline.net/Generics/News/Forest-Labs-files-lawsuit-to-stop-generic-memantine
2.   GaBI Online - Generics and Biosimilars Initiative. Alzheimer generic launched in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 9]. Available from: www.gabionline.net/Generics/News/Alzheimer-generic-launched-in-the-US
3. 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 Oct 9]. Available from: www.gabionline.net/Generics/News/Forest-Labs-files-lawsuit-to-stop-generic-memantine

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Source: Allergan,US FDA

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