Mylan NV announced the launch of memantine hydrochloride tablets USP, 5 mg and 10 mg, the generic version of Forest's Namenda Tablets, in the United States on Tuesday.
Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for memantine hydrochloride tablets, used for treating moderate to severe Alzheimer's-type dementia.
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, according to IMS Health Inc.
Because Mylan was one of the first applicants to submit a complete ANDA with a paragraph IV certification, it has 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 Dec. 31, 2014, according to IMS Health.
Mylan, a global pharmaceutical company, offers a growing portfolio of approximately 1,400 generic pharmaceuticals and several brand medications. Mylan also offers a wide range of antiretroviral therapies, upon which nearly 50 percent of HIV/AIDS patients in developing countries depend. Mylan also is a generics and specialty pharmaceutical company providing products to customers in approximately 150 countries and territories.