Mylan Inc. (Nasdaq: MYL) today announced that it has launched Olanzapine Orally Disintegrating Tablets (ODT), 5 mg, 10 mg, 15 mg and 20 mg, the generic version of Eli Lilly and Company's Zyprexa Zydis® 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 for the treatment of schizophrenia or the acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder.
Olanzapine ODT, 5 mg, 10 mg, 15 mg and 20 mg, had U.S. sales of approximately $120.8 million for the 12 months ending March 31, 2014, according to IMS Health.
Currently, Mylan has 300 ANDAs pending FDA approval representing $105.3 billion in annual brand sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $25.4 billion in annual brand sales, for the 12 months ending Dec. 31, 2013, according to IMS Health.