Mylan N.V. has launched in the United States memantine hydrochloride tablets USP, 5 mg and 10 mg, which is the generic version of Allergan’s (formerly called Actavis) Namenda tablets. Mylan received final approval from the US Food and Drug Administration for its abbreviated new drug application (ANDA) for this product, which is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.

Memantine hydrochloride tablets USP, 5 mg and 10 mg, had US sales of approximately $1.4 billion for the 12 months ending March 31, 2015, according to IMS Health, and as reported by Mylan. Mylan was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification and has therefore been granted 180 days of shared generic drug marketing exclusivity, according to the company.

In May 2015, Allergan (formerly called Actavis) confirmed that a panel of the US Court of Appeals for the Second Circuit issued a ruling upholding a December 15, 2014 preliminary injunction requiring the company to continue distribution of Namenda (memantine HCl) immediate-release tablets, which are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Allergan has commercialized an extended-release version of the drug, Namenda XR (memantine HCl) , a higher dose, once-daily formulation of Namenda and had sought to discontinue the immediate-release version of the drug. Allergan became the new corporate name of the combined companies of Allergan and Actavis following the close of the approximate $70 billion acquisition of Allergan by Actavis earlier this year. The company kept the Actavis name for the company’s US and Canadian generic drug businesses.

Source: Mylan