Generics giant Mylan has launched generic versions of fenofibrate capsules, cidofovir injection and levalbuterol. The company has also resolved patent litigation with Shionogi and Andrx related to metformin.
Generic fenofibrate capsules
Mylan announced on 25 February 2013 that its subsidiary Mylan Pharmaceuticals had begun shipping fenofibrate capsules, 43 mg and 130 mg. The product is the generic version of Lupin Atlantis Holdings’s Antara capsules, which are indicated as an adjunct to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol, triglycerides, and apolipoprotein B (Apo B) and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolaemia or mixed dyslipidemia and to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Fenofibrate has not been shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus.
Fenofibrate capsules 43 mg and 130 mg had US sales of approximately US$60 million for the 12 months ending 30 September 2012, according to IMS Health.
Cidofovir generic
Privately held US product development company, InnoPharma announced on 8 March 2013 the launch of cidofovir injection, a generic drug equivalent of Gilead Sciences Vistide in 5 mL single-use vials.
InnoPharma developed the generic formulation of cidofovir, which will be marketed in the US by Mylan. Cidofovir injection is indicated for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome.
Settlement with Shionogi and Andrx
Mylan announced on 13 March 2013 that its subsidiary Mylan Pharmaceuticals had reached a deal with Shionogi and Andrx resolving patent litigation related to metformin hydrochloride extended-release tablets, 500 mg and 1,000 mg. The product is the generic version of Shionogi’s Fortamet, and is indicated as an adjunct to diet and exercise to lower blood glucose.
Under the terms of the settlement agreement, Mylan may launch its generic version on 1 August 2013, or earlier under certain conditions.
Fortamet 500 mg and 1,000 mg had US sales of approximately US$125 million for the 12 months ending 30 September 2012, according to IMS Health.
Levalbuterol generic
Mylan announced on 18 March 2013 that its subsidiary Mylan Specialty had received FDA approval for its generic levalbuterol inhalation solution, 0.31 mg/3 mL (0.0103%), 0.63 mg/3 mL (0.021%), and 1.25 mg/3 mL (0.042%), (Concentrate). The product is the generic version of Sunovion’s Xopenex Inhalation Solution, which is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children > 6 years with reversible obstructive airway disease.
Xopenex 0.31 mg/3 mL, 0.63 mg/3 mL, and 1.25 mg/3 mL had US sales of approximately US$438.8 million for 2012, according to IMS Health.
Currently, Mylan has 182 Abbreviated New Drug Application (ANDAs) pending FDA approval representing US$80 billion in annual sales, according to IMS Health. Thirty-six of these pending ANDAs are potential first-to-file opportunities, representing US$21.1 billion in annual brand-name sales, for the 12 months ending 30 June 2012, according to IMS Health.
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Source: InnoPharma, Mylan
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