ELITE PHARMACEUTICALS INC /NV/

Elite Pharmaceuticals, Inc.

Overview

• Corporate status: Nevada corporation (formerly Delaware; reincorporated in Nevada on January 5, 2012).
• Core business: Specialty pharmaceutical company focused on development and manufacture of oral, controlled-release products and generic pharmaceuticals. Strategy targets generic versions of controlled-release drugs with high barriers to entry.
• Primary facilities: Northvale Facility — 135, 144, and 165 Ludlow Avenue, Northvale, NJ. Facility operates under cGMP and is a United States DEA-registered site for R&D and manufacturing. Website: www.elitepharma.com.
• Operating focus: Single operating segment — ANDA (generic) products. NDA (branded) activities have been paused; recent reported revenue is from the ANDA segment.

Products and commercial activity

• Commercial footprint: Owns, licenses, manufactures, sells, distributes, or receives royalties from a portfolio of branded and generic products. Product families and examples include:
  • Branded therapeutics launched via Elite Labs and licensed/licensed-through partners: Phentermine (15 mg, 30 mg, 37.5 mg); Phendimetrazine 35 mg; Naltrexone 50 mg; Isradipine 2.5 mg and 5 mg; Trimipramine 25/50/100 mg; various Adderall- and Dantrium-related products; Dantrolene; Loxapine; Methotrexate; APAP Codeine; APAP Hydrocodone; Lisdexamine dimesylate; Oxycodone/acetaminophen combinations; Methadone; Doxycycline Hyclate (with Praxgen); Ropinirole ER; and others.
  • Abuse-deterrent and development programs: SequestOx™ — Immediate-Release Oxycodone with sequestered naltrexone (development paused). Abuse-deterrent product development is a strategic area.
• FDA filings and approvals:
  • SequestOx™ (abuse-deterrent opioid): NDA filed January 14, 2016; FDA issued a Complete Response Letter in 2016; subsequent pilot/modified studies were conducted; development is paused and the company continues to evaluate market and development considerations.
  • Other approved or in-development products include multiple ANDAs and branded products under prior license arrangements. The Precision Dose agreement expired in 2025. The Dexcel agreement for Amphetamine IR and related products began in 2021 with first shipment in 2025.
• Recently added/launched products (2022–2026):
  • Methotrexate Tablets — FDA approval May 20, 2024; launched August 2024; manufactured at Northvale.
  • APAP Codeine Tablets — acquired via Nostrum Asset Purchase Agreement; launched October 2024; manufactured at Northvale.
  • APAP Hydrocodone Tablets — launched December 2024; licensing via Nostrum.
  • Lisdex Capsules — FDA approval November 2024; launched December 2024; manufactured at Northvale.
  • Oxy APAP Tablets — Nostrum asset; launched April 2025; manufactured at Northvale.
  • Methadone Tablets — Nostrum asset; launched April 2026; manufactured at Northvale.
  • Doxycycline Hyclate Tablets — FDA approval April 2022; joint ownership with Praxgen.
  • Ropinirole ER — FDA approval November 2025 (generic Requip XL); manufactured at Northvale.
• Proprietary and operational focus: Continued development of abuse-deterrent technology and maintenance of advanced manufacturing capabilities for generics, with a pipeline that includes additional generic and potential co-development opportunities.

Customers and revenue

• Customer concentration: The six largest customers accounted for more than 75% of revenues in the year ended March 31, 2026.
• Revenue:
  • ANDA segment revenue for year ended March 31, 2026: $148.9 million.
  • ANDA segment revenue for year ended March 31, 2025: $84.0 million.
• A substantial portion of revenue is derived from a limited number of products and customers, which creates concentration risk.

Employees

• Full-time employees: 65 as of June 25, 2026.
• Workforce: All full-time employees engaged across manufacturing, operations, administration, R&D, and related functions. No union representation reported.

Patents and intellectual property

• U.S. patent 9,056,054 (expires 2030).
• U.S. patent 10,213,388 (expires 2030).
• IP strategy: Pursues additional patent protection and corresponding foreign filings. Trademark: SequestOx™ owned by Elite.
• During the year ended March 31, 2026, an impairment related to Loxapine Capsules was recognized following reassessments of future cash flows.

Licensing, manufacturing, and development agreements

• Precision Dose License Agreement (Sept 10, 2010 – Sept 10, 2025): Licensed marketing and distribution for several products in the U.S., Puerto Rico, and Canada; included license fees and milestone payments; agreement expired in 2025.
• Prasco Non-Exclusive License Agreement (April 5, 2023 – terminated March 31, 2025): Manufacturing and supply arrangement with exclusive U.S. distribution rights during the agreement term; terminated March 31, 2025.
• Dexcel Agreement for Israel (Dec 6, 2021): Elite manufactures and packages Amphetamine IR products under Dexcel’s label; Dexcel handles sales, marketing, and distribution; first shipment under this agreement occurred July 2025.
• Nostrum Asset Purchase Agreement (June 17, 2024): Acquisition of rights to APAP Codeine Tablets, APAP Hydrocodone Tablets, Oxy APAP Tablets, Lisdex Capsules, and Methadone Tablets. Licenses are royalty-free, non-exclusive, perpetual licenses for manufacturing technology and know-how. Products from these assets launched between 2024 and 2026.

Regulatory environment and manufacturing

• Northvale Facility is cGMP-compliant and DEA-registered for research, development, and manufacturing.
• Product approvals follow NDA and ANDA regulatory paths; REMS and post-approval requirements can apply depending on the product.
• The business faces risks related to regulatory changes, approval timelines and delays, pricing and reimbursement policies, and competitive pressures common to the generic pharmaceutical industry.

Summary snapshot

• Business focus: Develops and manufactures generic and branded pharmaceutical products (primarily through ANDAs) with emphasis on controlled-release and high-barrier-to-entry formulations. Maintains proprietary and licensed product lines and manages manufacturing at the Northvale facility.
• Revenue and scale: ANDA revenue of $148.9 million for fiscal year ended March 31, 2026 (versus $84.0 million in 2025). Six largest customers represented more than 75% of 2026 revenues.
• Resources: 65 full-time employees as of June 25, 2026.
• Intellectual property: Two U.S. patents expiring in 2030; SequestOx™ trademark; ongoing work on abuse-deterrent technology (program currently paused).
• Key relationships: Precision Dose (license expired 2025), Prasco (non-exclusive license ended 2025), Dexcel (Israel distribution arrangement; first shipment 2025), and Nostrum Asset Purchase (acquisitions and manufacturing rights 2024–2026).
• Capital and risks: Recognized impairment related to Loxapine; revenue concentration among a small number of customers and products; dependence on third-party suppliers for raw materials; regulatory and competitive risks inherent to the pharmaceutical and generic drug markets.