Glenmark Pharmaceuticals’ arm - Glenmark Pharmaceuticals Inc., USA, has announced the availability of ezetimibe, the first and only generic version of Zetia (Merck) in the United States for the treatment of high cholesterol. The availability of ezetimibe is the result of a licensing partnership with Par Pharmaceutical, an Endo International plc operating company, with whom Glenmark will share profits.
Glenmark and its partner, Endo will be entitled to 180 days of generic drug exclusivity for ezetimibe as provided for under FD&C Act. According to IMS Health data for the 12-month period ending October 2016, annual US sales of Zetia 10 mg were approximately $2.3 billion.
Ezetimibe is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B) in patients with primary (heterozygous familial and non-familial) hyperlipidemia.
