Endo International subsidiary Par Pharmaceutical has begun the shipping process for ezetimibe 10 mg tablets, which is the generic form of ZETIA, developed by Merck.
Par Pharmaceuticals has the rights to market and distribute ezetimibe in the United States and, according to the first-to-file ANDA status of its licensing partners, Glenmark Pharmaceuticals is permitted to Hatch-Waxman generic marketing exclusively. Par will share the profits of the product with Glenmark.
"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," Par Pharmaceuticals President Tony Pera said. "Par remains committed to providing patients access to high quality and affordable medicines."
ZETIA was developed for the reduction of increased LDL cholesterol levels in patients who have hyperlipidemia and is to be used along with a healthy diet.
"Glenmark has a deep heritage of bringing safe, effective and affordable medicines to patients around the world," API President Robert Matsuk said. "Our partnership with Endo 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."