Mylan N.V. and Mylan Inc. announced the U.S. launch of Buprenorphine Hydrochloride Sublingual Tablets (2 mg and 8 mg) and Disulfiram Tablets USP (250 mg and 500 mg) which are the generic versions of Reckitt Benckiser's Subutex® Sublingual Tablets and Odyssey Pharmaceutical's Antabuse® respectively.
Mylan received final approvals from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for these products out of which Buprenorphine Hydrochloride indicated for the treatment of opioid dependence and Disulfiram for 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.
For Buprenorphine Hydrochloride Sublingual Tablets, 2mg and 8mg had U.S. sales of approximately $107.8 million and for disulfiram Tablets USP, 250 mg and 500 mg, had U.S. sales of approximately $16.4 million for the 12 months ending December 31, 2014, according to IMS Health.
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.
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