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

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...
Blood Pressure and Cholesterol-lowering Drugs Continue to Improve Survival After a Decade
News | Pharmaceuticals | August 27, 2018
Blood pressure and cholesterol-lowering drugs continue to improve survival in patients with hypertension after more...
Pfizer Announces Positive Topline Results from Phase 3 ATTR-ACT Study
News | Pharmaceuticals | April 06, 2018
Pfizer Inc. announced that the Tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study met its primary endpoint...
Humanetics Presents Data on Drug to Protect Cardiac Cells From Space-Like Radiation

Photo from NASA

News | Pharmaceuticals | February 01, 2018
February 1, 2018 –Humanetics Corporation (Humanetics) has recently completed two research studies funded by the Natio
Xarelto Significantly Reduces Major Cardioavascular Events in Stable CAD and PAD Patients
News | Pharmaceuticals | October 18, 2017
October 18, 2017 — Results from the pivotal Phase 3 COMPASS study found that the...
News | Pharmaceuticals | October 04, 2017
October 4, 2017 — MyoKardia Inc.
News | Pharmaceuticals | September 12, 2017
September 12, 2017 — Inclisiran lowers low-density lipoprotein (LDL, or “bad”) cholesterol for up to one year in pati
Merck Announces Results of REVEAL Outcomes Study of Anacetrapib
News | Pharmaceuticals | September 11, 2017
Merck and researchers in the Clinical Trial Service Unit at the University of Oxford announced the publication and...
Overlay Init