Mylan announced the U.S. launch of Rasagiline Tablets, 0.5 mg and 1 mg, a generic version of the reference listed drug, Teva’s Azilect 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 in the treatment of Parkinson’s disease.
Rasagiline Tablets, 0.5 mg and 1 mg, had U.S. sales of approximately $343 million for the 12 months ending March 31, 2017, according to QuintilesIMS Health.
Currently, Mylan has 234 ANDAs pending FDA approval representing approximately $104 billion in annual brand sales, according to QuintilesIMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $42.3 billion in annual brand sales, for the 12 months ending December 31, 2016, according to QuintilesIMS Health. Currently, one out of every 13 prescriptions filled in the U.S. – brand-name or generic – is a Mylan product.