Elite Pharmaceuticals, Inc recently announced the signing of a license, manufacturing, and supply agreement with Glenmark Pharmaceuticals, Inc., USA to market two Elite generic products in the US with the option to add products in the future.
Through the agreement, Glenmark will sell and distribute the products, and Elite will receive from Glenmark, manufacturing and license fees. Glenmark will have semi-exclusive marketing rights to the ANDA approved product, phendimetrazine 35-mg tablets and exclusive marketing rights to an undisclosed pain product, currently under review by the FDA with an expected approval date in the third quarter of this year. Collectively, the brand products and their generic equivalents had total annual sales of approximately $33.6 million in 2017 according to QuintilesIMS Health data.
“The alliance with Glenmark will broaden market access for Elite’s generic products,” said Nasrat Hakim, President and CEO of Elite. “We are excited about the opportunity and look forward to adding more products to the alliance and continued growth for both companies. In addition to our SequestOx NDA filing, Elite currently has five ANDAs under review at the FDA, including two with our partner SunGen Pharma, and eight commercial products.”
Glenmark Pharmaceuticals Ltd. (GPL) is a global innovative pharmaceutical company with operations in more than 50 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development, primarily focused in the areas of oncology, respiratory disease, and dermatology. Glenmark has improved the lives of millions of patients by offering safe, affordable medications for nearly 40 years. For more information, visit www.glenmarkpharma-us.com.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company, which is developing a pipeline of proprietary pharmacological abuse-deterrent opioid products as well as niche generic products. Elite specializes in oral sustained and controlled release drug products that have high barriers to entry. Elite owns generic products that have been licensed to TAGI Pharma, Epic Pharma, and Dr. Reddy’s Laboratories. Elite currently has eight commercial products being sold, five products filed with the FDA, additional approved products pending manufacturing site transfer and the NDA filing for SequestOx. Elite’s pipeline products include abuse-deterrent opioids that utilize the company’s patented proprietary technology and a once-daily opioid. These products include sustained release oral formulations of opioids for the treatment of chronic pain. These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. For more information, visit www.elitepharma.com.
