'Glenmark has a deep heritage of bringing safe, effective and affordable medicines to patients around the world,' said Robert Matsuk, President of North America and Global API at Glenmark Pharmaceuticals Ltd. sales of Zetia® 10 mg1 were approximately $2.3 billion2. Glenmark and its partner, Endo will be entitled to 180 days of generic drug exclusivity for ezetimibe as provided for under section 505(j)(5)(B)(iv) of the FD&C Act.Įzetimibe 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.Īccording to IMS Health data for the 12-month period ending October 2016, annual U.S. 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. NovemMumbai, India December 12, 2016: Glenmark Pharmaceuticals Inc., USA today announced the availability of ezetimibe, the first and only generic version of ZETIA® (Merck) in the United States for the treatment of high cholesterol.
Glenmark launches first and only generic version of Zetia® in the United States
