Mylan to introduce Femara generic

PITTSBURGH Mylan on Monday announced that it has entered into a settlement agreement with Novartis Pharmaceuticals that will allow the generic manufacture to introduce a generic version of Novartis' Femara, a breast-cancer treatment.

Under the agreement, Mylan is provided a patent license that will enable the company to market letrozole Tablets, 2.5 mg, prior to the expiration of Novartis’ patent.

Letrozole Tablets, which are used in the treatment of breast cancer, had U.S. sales of approximately $470 million for the 12 months ending Sept. 30, Mylan reported.

Additional terms related to the settlement were not disclosed, and the agreement is subject to review by the U.S. Department of Justice and the Federal Trade Commission.

Mylan was the first company to file a substantially complete Abbreviated New Drug Application. Currently, Mylan has 113 ANDAs pending U.S. Food and Drug Administration approval, 24 of which are potential first-to-file opportunities.