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Namenda XR Generics Coming Soon? US Court Rulings Clear Path For Multiple Launches

 
• By Sue Sutter

Seven companies hold final ANDA approval for Alzheimer's drug, but Allergan still has chance to block them as it seeks rehearing of appeals court's patent decision. Meanwhile, Amneal might block other generics if it can get an appeals court to grant it the 180-day marketing exclusivity for memantine extended-release it says that FDA unfairly denied it.

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The US launch of multiple generic versions of Allergan PLC's Namenda XR (memantine extended-release) may be imminent thanks to two recent court rulings involving the Alzheimer's dementia drug.

On Jan. 24, a federal district judge upheld FDA's determination that Amneal Pharmaceuticals LLC had forfeited its rights to 180-day generic marketing exclusivity because it failed to obtain abbreviated...

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