Amneal Pharmaceuticals LLC ("Amneal") will launch its AB-rated generic for Loestrin® 24 Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets) 1 mg/20 mcg, 75 mg the first week of January 2014. Amneal's exclusive First-to-File generic equivalent for this brand will be sold under the name Lomedia™ 24 Fe (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1mg/20mcg and Ferrous Fumarate Tablets, 75mg). Patients will be able to swallow the pill whole just as they did with Loestrin® 24 Fe.
"We learned that many patients were concerned upon finding that their prescribed medication was discontinued by the brand manufacturer," explains Jim Luce, Executive VP Sales & Marketing for Amneal. "We want those patients and their healthcare providers to know the generic equivalent is coming soon—that they will be able to continue using the therapy they've come to know and trust."
Loestrin® 24 Fe was first approved by the FDA in February 2006. According to June 2013 IMS market data, annual U.S. sales were $510.6 million before its recent discontinuation with nearly 9 million 28-day packs sold annually, supplying an estimated 800,000 patients.
Amneal plans to sell Lomedia™ 24 Fe to wholesalers, distributors and direct to the trade. The company expects its new generic product to be in pharmacies the first week in January 2014.
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