Elite Pharmaceuticals & SunGen Pharma File ANDA

Elite Pharmaceuticals, Inc. recently announced it filed an Abbreviated New Drug Application (ANDA) with the US FDA for a generic version of an antibiotic product. This is the third ANDA that Elite co-developed and filed with SunGen Pharma, LLC. According to QVIA (formerly QuintilesIMS Health) data the branded product for this antibiotic and its equivalents had total annual US sales of approximately $94 million for the 12 months ending September 30, 2018.

The product is jointly owned by Elite and SunGen. Elite will manufacture and package the product on a cost-plus basis.

“This is the third ANDA developed and filed with our partner, SunGen. Our first ANDA with SunGen, a generic version of Adderall, was approved this December, and we look forward to additional approvals and filings in the future,” said Nasrat Hakim, President and CEO of Elite. “In addition to our SequestOx NDA filing, Elite has a total of four ANDAs under FDA review.”

“We are pleased to have another ANDA filed with the FDA through our partnership with Elite as we work on the launch of the recently approved generic Adderall,” added Dr. Jim Huang, Co-CEO of SunGen.

SunGen Pharma, LLC is a privately held specialty pharmaceutical company that develops, contract manufactures, and sells pharmaceutical finished products. SunGen specializes in the development of oral solid extended-release and complex injectable products. SunGen has business partnerships with many US-based generic pharmaceutical companies to develop, manufacture, and sell several pharmaceutical products in the US.

Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that 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 and Glenmark Pharmaceuticals, Inc., USA. Elite currently has 12 approved generic products, three generic products filed with the FDA, two approved generic products pending manufacturing site transfer, and an NDA filed for SequestOx. For more information, visit www.elitepharma.com.