Glenmark launches generic version of cholesterol drug Zetia in US market
Glenmark and its partner Endo will be entitled to 180 days of generic drug exclusivity for ezetimibe.
Glenmark Pharmaceuticals Inc., USA, on Monday announced launch of generic version of Zetia in the US market.
"We have launched ezetimibe, the first and only generic version of Zetia (Merck) in the United States for the treatment of high cholesterol," a statement issued here said.
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, it said.
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 hyperlipidemia.
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.
"Our partnership with Par to bring the first generic version of ZETIA to market only underscores our joint commitment to bridging the gap between patients and the medicines they need most," Glenmark
Pharmaceuticals President of North America and Global API Robert Matsuk said.
"We, along with our partners at Glenmark, are proud to be able to offer patients managing their cholesterol levels the first generic version of Zetia," President of Par Pharmaceutical Tony Pera said.
Glenmark's current portfolio consists of 111 products authorized for distribution in the US marketplace and 64 ANDAs pending approval with the US Food and Drug Administration.