PITTSBURGH — Mylan on Thursday today launched Perphenazine Tablets USP, 2 mg, 4 mg, 8 mg and 16 mg in the United States. It is a generic version of the reference listed drug, Trilafon Tablets 2 mg, 4 mg, 8 mg and 16 mg, originally marketed by Schering.
Mylan previously received final approval from the Food and Drug Administration for its Abbreviated New Drug Application for this product, which is used in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults.
Perphenazine Tablets USP, 2 mg, 4 mg, 8 mg, and 16 mg, had U.S. sales of approximately $41 million for the 12 months ending Feb. 28, according to IMS Health.
Currently, Mylan has 236 ANDAs pending FDA approval representing approximately $104.3 billion in annual brand sales, according to IMS Health. Forty-six of these pending ANDAs are potential first-to-file opportunities, representing $42.7 billion in annual brand sales, for the 12 months ending Dec. 31, 2016.