The Memantine hydrochloride tablets are the generic version of Forest laboratories’ Namenda Tablets.
The company has also received final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for this product.
According to IMS Health, Memantine Hydrochloride Tablets USP, 5mg and 10mg, had US sales of about $1.4bn for the 12 months ending 31 March 2015.
The company noted that it was one of the first 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.
Around 270 of Mylan ANDAs that represent $107.2bn in annual sales are still awaiting clearances from the FDA, with 47 of them being potential first-to-file opportunities, signifying $33.3bn in annual brand sales, for the year ending 31 December 2014.