Amneal to launch generic contraceptive

Amneal's product to compete exclusively against branded Loestrin 24 Fe for 180 days

BRIDGEWATER, N.J. — Generic drug maker Amneal Pharmaceuticals will launch its version of a contraceptive product at the beginning of January, the drug maker said.

Amneal said it would launch its version of 24 Fe (norethindrone acetate and ethinyl estradiol tablets; ferrous fumarate tablets) in the 1 mg/20 mcg and 75 mg strength. As the first company to successfully file for Food and Drug Administration approval of the drug, Amneal's product will have 180 days in which to compete exclusively against the branded version.

Loestrin 24 Fe had sales of $510.6 million during the 12-month period that ended in June 2013, according to IMS Health. The maker of branded Loestrin 24 Fe, Ireland-based Warner Chilcott, was acquired this year by Actavis.


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