Mylan and Dr Reddy’s launch Memantine hydrochloride tablets in the US

Both Mylan and Dr. Reddy’s have launched Memantine hydrochloride tablets USP, 5 mg and 10 mg, which is the generic version of Forest’s Namenda® Tablets, in the US.

The patents protecting Namenda expired Saturday. Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.

Memantine hydrochloride tablets had US sales of $1.4b for the 12 months ending March 2015

Memantine hydrochloride tablets USP, 5 mg and 10 mg, had US sales of approximately $1.4 billion for the 12 months ending 31 March 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 31 December  2014, according to IMS Health.

Dr. Reddy’s Memantine hydrochloride tablets USP, 5 mg is available in bottle count size of 60 and the Memantine hydrochloride tablets USP, 10 mg are available in bottle count sizes of 60 and 500.