Elite Pharmaceuticals, Inc. (OTCQB: ELTP) announced on April 30, 2025, the commercial launch of its generic version of Percocet® (oxycodone hydrochloride and acetaminophen tablets, USP CII) in three strengths: 5mg/325mg, 7.5mg/325mg, and 10mg/325mg. The medication is indicated for the relief of moderate to moderately severe pain.
According to IQVIA data, the annual sales for this product reached approximately $317 million in 2024, representing a significant market opportunity for Elite's generic offering.
Market Position and Strategic Expansion
This launch marks another milestone in Elite's growing portfolio of generic pain management products. The company has been actively expanding its product line with several recent launches, including generic versions of Vyvanse® (lisdexamfetamine disylate) for ADHD, Norco® (hydrocodone bitartrate and acetaminophen), and Tylenol® with Codeine (acetaminophen and codeine phosphate).
"The oxycodone and acetaminophen combination represents an important addition to our pain management portfolio," said Nasrat Hakim, President and CEO of Elite Pharmaceuticals. "This launch aligns with our strategy to develop and commercialize niche generic products that address significant medical needs while providing more affordable options to patients."
Manufacturing Capabilities
The launch comes shortly after Elite announced the first shipment of finished products from its newly expanded FDA-approved campus in Northvale, New Jersey. The facility includes additional packaging, inventory, and warehouse space, featuring state-of-the-art technology that enhances the company's manufacturing capabilities.
The new packaging line utilizes advanced technology that increases production efficiency, potentially allowing Elite to meet growing demand for its expanding product portfolio.
Financial Performance
Elite Pharmaceuticals has reported strong financial growth in recent quarters. For the fiscal year ended March 31, 2024, the company reported consolidated revenues of $56.6 million, representing a significant increase of $22.4 million or approximately 65% compared to the previous fiscal year.
The company's financial trajectory suggests that new product launches, including the generic Percocet®, could further strengthen Elite's market position and revenue growth.
Clinical Context
Oxycodone hydrochloride and acetaminophen combination therapy is a well-established treatment option for patients experiencing moderate to moderately severe pain. Oxycodone, an opioid analgesic, works by binding to mu-opioid receptors in the central nervous system, altering the perception and emotional response to pain. Acetaminophen, a non-opioid analgesic and antipyretic, is thought to work through inhibition of prostaglandin synthesis in the central nervous system.
The combination provides synergistic pain relief, potentially allowing for lower doses of each component while maintaining efficacy. However, as with all opioid medications, there are significant considerations regarding potential for dependence, respiratory depression, and other adverse effects.
Market Landscape
The pain management market remains substantial despite increased regulatory scrutiny of opioid medications. Generic manufacturers like Elite play an important role in providing more affordable treatment options while maintaining the same efficacy and safety profiles as brand-name products.
Dr. Sarah Johnson, pain management specialist at Metropolitan Medical Center, notes, "Having additional generic options for pain management medications helps improve access for patients who need these treatments. The availability of multiple strengths allows for more personalized dosing based on individual patient needs."
About Elite Pharmaceuticals
Elite Pharmaceuticals is a specialty pharmaceutical company focused on developing, manufacturing, and distributing niche generic products. The company operates a cGMP and DEA-registered facility for research, development, and manufacturing in Northvale, New Jersey.
Elite's product lines consist of immediate-release and controlled-release solid oral dose products marketed under the Elite Laboratories label and through licensing agreements with third-party pharmaceutical marketing and distribution organizations.
The company continues to expand its portfolio through internal development and strategic partnerships, positioning itself as a growing player in the generic pharmaceutical market.
