Mylan N.V. (Nasdaq: MYL) today announced the U.S. launch of Memantine Hydrochloride Tablets USP, 5 mg and 10 mg, which is the generic version of Forest's Namenda® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) 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 U.S. sales of approximately $1.4 billion for the 12 months ending March 31, 2015, according to IMS Health. 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.
Currently, Mylan has 270 ANDAs pending FDA approval representing $107.2 billion in annual brand sales, according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file opportunities, representing $33.3 billion in annual brand sales, for the 12 months ending December 31, 2014, according to IMS Health.
SOURCE Mylan N.V.