Mylan N.V. and Mylan Inc. announced the US launch of buprenorphine hydrochloride sublingual tablets, 2 mg and 8 mg, a generic version of Reckitt Benckiser's Subutex sublingual tablets. Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of opioid dependence and is preferred for induction.
Mylan also launched disulfiram tablets USP, 250 mg and 500 mg, a generic version of Odyssey Pharmaceutical's Antabuse. The company has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to the best advantage.
According to IMS Health, buprenorphine hydrochloride sublingual tablets, 2mg and 8mg and disulfiram tablets USP, 250 mg and 500 mg, had US sales of approximately $107.8 million and $16.4 million respectively for the 12 months ending December 31, 2014.
Currently, Mylan has 281 ANDAs pending FDA approval representing $104.6 billion in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $27.3 billion in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.