Glenmark Pharmaceuticals Inc., USA 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 section 505(j)(5)(B)(iv) of the FD&C Act.

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.

According to IMS Health data for the 12-month period ending October 2016, annual US sales of Zetia 10 mg1 were approximately $2.3 billion.

Robert Matsuk, president of North America and Global API at Glenmark Pharmaceuticals Ltd. Said, "Glenmark has a deep heritage of bringing safe, effective and affordable medicines to patients around the world. 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."

“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,” said Tony Pera, president of Par Pharmaceutical. “Par remains committed to providing patients access to high quality and affordable medicines.”

Glenmark’s current portfolio consists of 111 products authorized for distribution in the US marketplace and 64 ANDA’s pending approval with the US Food and Drug Administration. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.