Elite Pharmaceuticals Inc Stock Price, News & Analysis

Elite Pharmaceuticals (OTCQB: ELTP), a specialty pharmaceutical company focused on niche generic products, has scheduled its Fiscal Year 2025 financial results release for June 30, 2025, followed by a conference call on July 1, 2025, at 11:30 AM EDT. Management will discuss financial and operating results while providing a business update. Shareholders can submit general questions by June 27 (5:00 PM EDT) and financial questions by June 30 (7:00 PM EDT) to dianne@elitepharma.com. The call can be accessed via domestic (1-800-346-7359) or international (1-973-528-0008) dial-in numbers using conference number 98840, with audio replay available at elite.irpass.com/events_presentations.

Elite Pharmaceuticals (OTCQB: ELTP) announced successful results from a pivotal bioequivalence study for an undisclosed anticoagulant generic drug. The study demonstrated bioequivalence to a branded product with annual sales of $27 billion (IQVIA, April 2025). The generic drug was tested in a randomized, balanced, single oral dose study under fasting conditions. The branded product currently has no generic competition and maintains unexpired patent protection. Elite plans to file an Abbreviated New Drug Application (ANDA) with the FDA, though commercialization depends on successful filing, FDA approval, and addressing patent issues.

Elite Pharmaceuticals has announced the commercial launch of its generic version of Percocet (oxycodone hydrochloride and acetaminophen tablets, USP CII) in three different strengths: 5mg/325mg, 7.5mg/325mg, and 10mg/325mg.

The medication is specifically indicated for the treatment of moderate to moderately severe pain. This strategic product launch targets a significant market opportunity, as IQVIA reported annual sales of approximately $317 million for this product in 2024.

As a specialty pharmaceutical company focused on developing niche generic products, Elite's entry into this market represents a significant milestone in their product portfolio expansion. The company trades on the OTCQB market under the symbol ELTP.

Elite Pharmaceuticals (OTCQB: ELTP) has achieved a significant operational milestone with the first product shipment from its newly FDA-approved expanded campus in Northvale, New Jersey. The facility at 144 Ludlow Avenue features advanced packaging capabilities, inventory space, and warehouse facilities.

The highlight of the expansion is a state-of-the-art packaging line that can process approximately 120 bottles per minute. This development enables Elite to repurpose existing packaging areas into additional manufacturing suites, substantially boosting production capacity. The expansion is strategically designed to accommodate the company's projected packaging requirements for the next five years.

Elite Pharmaceuticals (OTCQB: ELTP) reported financial results for Q3 FY2025 ended December 31, 2024. The company saw consolidated revenues of $14.4 million, representing an 8% decrease ($1.2 million) compared to the same period last year. Operating profits declined by 69% to $1.1 million, a $2.4 million decrease from the previous year.

The company attributed the performance decline to timing differences during the December holiday period, which resulted in shipment delays into the first week of January 2025. Elite Pharmaceuticals, which specializes in developing, manufacturing, and distributing niche generic products, has scheduled a conference call for February 14, 2025, at 11:30 AM EST to discuss these results and provide business updates.

Elite Pharmaceuticals (OTCQB: ELTP), a specialty pharmaceutical company focused on niche generic products, has scheduled its Q3 FY2025 financial results release for February 13, 2025. The company will host a conference call on February 14, 2025, at 11:30 AM EST to discuss financial and operating results, along with providing a business update.

Stockholders are invited to submit questions prior to the call, with general questions due by February 12, 2025 (5:00 PM EST) and financial questions by February 13, 2025 (7:00 PM EST). The conference call will be accessible via domestic (1-800-346-7359) and international (1-973-528-0008) dial-in numbers using conference number 98840.

Elite Pharmaceuticals (OTCQB: ELTP) has launched its generic version of Vyvanse® (Lisdexamfetamine Disylate) for treating attention deficit hyperactivity disorder (ADHD). The product is available in seven different strengths: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg capsules. The generic drug will be marketed and sold under the Elite Laboratories label. According to IQVIA data, the original drug recorded annual sales of approximately $4.3 billion for the twelve months ending October 2024.

Elite Pharmaceuticals (OTCQB: ELTP) has launched its generic version of Norco® (hydrocodone bitartrate and acetaminophen tablets, USP CII) in four different strengths: 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg, and 10mg/325mg. The medication is indicated for managing severe pain requiring opioid analgesics when alternative treatments are inadequate. According to IQVIA, the annual sales for this product reached approximately $300 million for the twelve months ending September 2024.

Elite Pharmaceuticals (OTCQB: ELTP) has received FDA approval for its generic version of Vyvanse (Lisdexamfetamine Dimesylate) capsules in seven different strengths ranging from 10 mg to 70 mg. The medication is designed to treat Attention Deficit Hyperactivity Disorder (ADHD). According to IQVIA data, the combined brand and generic market for this product recorded annual sales of $4.3 billion for the twelve months ending September 2024.