The settlement relates to a patent infringement litigation brought by Forest and Adamas in response to Amneal's abbreviated new drug application (ANDA) seeking approval to market generic versions of Allergan's NAMENDA XR
(memantine hydrochloride) extended release capsules.
Actavis global brands senior vice president David Nicholson said: "Namzaric combines, in one capsule, two complementary therapeutic agents which are often co-prescribed as approximately 70% of Namenda XR
patients are also on AChEI therapy.
The oral solution of NAMENDA and once-daily NAMENDA XR
(memantine HCl) extended-release capsules will continue to be available.
In November we were pleased to announce that we entered into an agreement with Adamas Pharmaceuticals for the development and commercialization of a fixed dose combination of Namenda XR
and donepezil as a once-daily therapy for the treatment of moderate and severe dementia of the Alzheimer's type.
The two companies have been examining a pill that unites Namenda XR
with donepezil, or Aricept.
The efficacy and safety of NAMENDA XR
was established in a 24 week, randomized, double-blind, placebo-controlled trial of 677 outpatients on a stable dose of acetylcholinesterase inhibitors (AChEl).
We also still have Namenda XR
, a 28 mg once-daily extended-release formulation of memantine for the treatment of moderate and severe Alzheimer's disease, which has been approved, but not yet launched.
Since the launch of NAMENDA XR
(memantine hydrochloride) in 2013, the two medications, NAMENDA XR
and donepezil, have been commonly prescribed in combination with one another to treat the symptoms of moderate to severe Alzheimer's disease.
received approval for the treatment of moderate to severe dementia of the Alzheimer's type.
Memantine ER is the active ingredient in the currently marketed NAMENDA XR
, which is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
is a 28 mg once-daily extended-release formulation of memantine.
(memantine HCl) extended release capsules are a 28mg once-daily formulation of NAMENDA approved for the treatment of moderate to severe dementia of the Alzheimer's type.