News | May 04, 2010

Companies Partner to Produce Generic Zetia

May 4, 2010 – A deal has been struck to produce a generic version of Merck & Company’s Zetia (ezetimibe). In the United States, the cholesterol modifying agent has annual U.S. sales of about $1.4 billion, according to IMS Health data.

Par Pharmaceutical Inc. yesterday announced it entered into an exclusive licensing agreement with Glenmark Generics to market ezetimibe 10 mg tablets. Glenmark believes it is the first to file a U.S. Food and Drug Administration (FDA) abbreviated new drug application (ANDA) for generic drug approval of the pharmaceutical. The ANDA includes a paragraph IV certification for the product, which would potentially provide 180 days of marketing exclusivity. In April 2009, Glenmark was granted tentative approval for its product by the FDA.

Under the terms of the licensing and supply agreement, Par has made a payment to Glenmark for exclusive rights to market, sell and distribute ezetimibe in the United States. The companies will share in profits from the sales of the product.

Glenmark is currently involved in patent litigation concerning the drug in the U.S. District Court for the District of New Jersey. Par will share control and costs with Glenmark for ongoing litigation. A trial is scheduled to commence May 12.

Par Pharmaceutical is a U.S.-based specialty pharmaceutical company. It develops, manufactures and markets generic drugs and niche proprietary pharmaceuticals.

For more information: www.parpharm.com

Related Content

Vascepa Markedly Reduces First, Repeat and Total Cardiovascular Events
News | Pharmaceuticals | March 29, 2019
Taking a high dose of icosapent ethyl significantly reduces the occurrence of first, subsequent and total ischemic...
Bempedoic Acid Combination Tablet Significantly Lowers LDL-Cholesterol

Image courtesy of Esperion

News | Pharmaceuticals | March 25, 2019
Phase 3 results from Study 2, also known as CLEAR WISDOM, of bempedoic acid were recently presented at the American...
Aurobindo Pharma Adds to Nationwide Valsartan Blood Pressure Medication Recall
News | Pharmaceuticals | January 10, 2019
January 10, 2019 — Aurobindo Pharma USA Inc.
Mylan Expands Nationwide Recall of Valsartan Blood Pressure Medication
News | Pharmaceuticals | December 11, 2018
December 11, 2018 — Mylan Pharmaceuticals is expanding its consumer-level voluntary nationwide recall to include all
Farxiga Reduces Heart Failure Hospitalization, Cardiovascular Death for Type 2 Diabetes
News | Pharmaceuticals | November 15, 2018
AstraZeneca announced positive full results from the DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) for...
Vascepa and Statins Significantly Reduce Cardiovascular Events in the REDUCE-IT trial. #AHA #AHA18 #AHA2018
News | Pharmaceuticals | November 13, 2018
A study in the current edition of the New England Journal of Medicine shows that a particular treatment significantly...
Evolocumab Benefits High-Risk Patients With Established Cardiovascular and Chronic Kidney Disease
News | Pharmaceuticals | October 31, 2018
Amgen announced a new Repatha cardiovascular outcomes study (FOURIER) analysis evaluating the effects of Repatha (...
Jardiance Improves Life Expectancy for Adults With Type 2 Diabetes and Cardiovascular Disease
News | Pharmaceuticals | October 11, 2018
Novel results from the landmark EMPA-REG OUTCOME trial suggest that treatment with Jardiance positively impacts life...
Effect of Daily Aspirin on First-Time Heart Attack and Stroke Risk Inconclusive
News | Pharmaceuticals | September 04, 2018
The jury is still out on whether people at moderate risk of a first heart attack or stroke should take daily aspirin to...
Overlay Init