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news.Mylan has signed a settlement and license agreements with Forest Laboratories and Merz Pharmaceuticals regarding Namenda tablets, known generically as Memantine Hydrochloride (HCl) tablets.
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Mylan said that following the settlement agreement, it is expected to get the right to market Memantine HCl in the US on January 11, 2015, or earlier, under certain circumstances.
Namenda is used for treating moderate to severe Alzheimer-type dementia. Namenda is a NMDA-receptor antagonist. It works by blocking excess activity of a substance in the brain called glutamate, which may reduce the symptoms associated with Alzheimer disease.
Namenda is available for oral administration as capsule-shaped, film-coated tablets containing 5mg and 10mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate.
Mylan claimed that currently it has 131 ANDAs pending FDA approval. Forty-one of these pending ANDAs are potential first-to-file opportunities.