The company also secured 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 schizophrenia or the acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder.
At present, the company has 300 ANDAs pending FDA approval representing $105.3bn in annual brand sales, and 42 of these pending ANDAs are potential first-to-file opportunities, representing $25.4bn in annual brand sales, for the 12 months ending Dec. 31, 2013, according to IMS Health.
The company provides a growing portfolio of over 1,300 generic pharmaceuticals and several brand medications.
Additionally, the company offers a wide range of antiretroviral therapies, upon which about 40% of HIV/AIDS patients in developing countries depend.