Mylan Inc. has launched eszopiclone tablets 1 mg, 2 mg and 3 mg, the generic version of Sunovion Pharmaceuticals Inc.'s Lunesta. 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 insomnia.
Eszopiclone tablets 1 mg, 2 mg, 3 mg had US sales of approximately $851.8 million for the 12 months ending December 31, 2013, according to IMS Health.
Currently, Mylan has 187 ANDAs pending FDA approval representing $94.9 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 December 31, 2013, according to IMS Health. When including ANDAs associated with Mylan's recent acquisition of Agila, the company now has a total of 304 ANDAs pending FDA approval.
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