Elite Pharmaceuticals

What Elite Pharmaceuticals does

Elite Pharmaceuticals is a specialty pharmaceutical company founded in 1997 and headquartered in Northvale, New Jersey. The company develops and manufactures oral, controlled-release niche generic drug products and operates an 85,000-square-foot cGMP- and DEA-registered facility for research, development, manufacturing, and packaging. Its portfolio spans 17+ FDA-approved generic products distributed nationally under the Elite Laboratories label, with select products licensed to TAGI Pharma for distribution. Therapeutic coverage includes CNS stimulants (generics equivalent to Adderall, Adderall XR, and Vyvanse), opioid analgesics (Norco, Percocet, and methadone equivalents, all subject to REMS), skeletal muscle relaxants (Dantrolene), antipsychotics (Loxapine), cardiovascular agents (Isradipine), bariatric products (Phentermine, Phendimetrazine), antidepressants (Trimipramine), and antimetabolites (Methotrexate). Elite focuses on complex dosage forms with high barriers to entry, positioning away from commodity generics that face large-scale competition.

The company's core proprietary technology is its ART™ (Abuse-Resistant Technology) platform: a multi-particulate capsule system that pairs an opioid agonist with a naltrexone antagonist. When taken as prescribed, the naltrexone passes through unreleased and the agonist delivers over time as intended; if the beads are crushed or dissolved, the naltrexone releases to block euphoria by binding to brain receptors. The platform is offered in One Bead and Two Bead architecture variants and is applicable across all opioid pain-management compounds. ART™ is a registered trademark and underlies the company's branded pipeline, most notably SequestOx (ELI-200), an abuse-deterrent opioid for pain management with an NDA currently pending FDA approval. Two additional products — Doxycycline Hyclate tablets and Ropinirole ER tablets (generic Requip XL) — are FDA approved but not yet commercialized.

Elite generates revenue primarily through product sales of its generic pharmaceutical products, with supplemental one-time license income from the TAGI Pharma distribution arrangement. Reported financial momentum has been pronounced: Q3 FY2026 (three months ended December 31, 2025) revenue was $31.6 million, up 120% year-over-year; Q2 FY2026 revenue was $36.3 million, up 92% year-over-year; nine-month FY2026 revenue surpassed $100 million; and full-year reported revenue was approximately $140 million as of June 2026. Q3 FY2026 net income reached $18.6 million on income from operations of $9.0 million (up ~721% YoY), driven primarily by the launch of lisdexamfetamine and naltrexone products. The company is led by Chairman, President, and CEO Nasrat Hakim, who has held those roles since August 2013 and brings more than 30 years of pharmaceutical industry experience from prior senior quality and regulatory roles at Actavis and Alpharma.

Name

Elite Pharmaceuticals

Legal name

Elite Pharmaceuticals Inc.

Website

https://elitepharma.com

Company type

Public

Founded year

1997

Operating status

Operating

Headcount range

51–100 employees

Short description

Elite Pharmaceuticals is a specialty pharmaceutical company that develops and manufactures oral controlled-release niche generic drug products under its Elite Laboratories label, and operates a proprietary ART™ abuse-deterrent opioid technology platform serving healthcare professionals and patients across the United States.

Ownership category

akta.pro rank

Product category

Specialty Generic Pharmaceuticals

NAICS

Pharmaceutical and Medicine Manufacturing (32541), Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Small-Molecule Generics (Branded/Unbranded) (HLAIABAA)

akta.pro secondary industry

Pain Management & Anesthesiology Pharmaceuticals (HLAIAAAN)

Keywords

• Generic pharmaceuticals
• Controlled-release drugs
• Abuse-deterrent opioids
• Specialty pharma manufacturing
• Oral solid dosage forms

Headquarters

HQ city

Northvale

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Operations, Personnel, Technology or R&D, Supply Chain, Marketing or Sales

Revenue model

1. Generic Pharmaceutical Product Sales: Revenue generated from manufacturing and selling generic pharmaceutical products under the Elite Laboratories label, including products such as lisdexamfetamine, naltrexone, methadone hydrochloride tablets, and other controlled-release generic drugs. The company also earns licensing revenue from products licensed to TAGI Pharma.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

Elite Pharmaceuticals develops, manufactures, and distributes oral controlled-release niche generic pharmaceutical products under its Elite Laboratories label across pain management, allergy, cardiovascular, CNS, and infection therapeutic areas. The company also develops abuse-deterrent opioid products based on its proprietary ART™ platform and licenses selected products to TAGI Pharma for distribution.

Product overview

Elite Pharmaceuticals is a specialty pharmaceutical company operating a portfolio of 17+ generic pharmaceutical products distributed under the Elite Laboratories label, complemented by one branded abuse-deterrent product in late-stage development. The company's generic portfolio spans multiple therapeutic categories including CNS stimulants (Adderall®, Adderall XR®, Vyvanse® equivalents), opiate analgesics (Norco®, Percocet®, Methadone), antipsychotics (Loxapine), skeletal muscle relaxants (Dantrolene), cardiovascular medications (Isradipine, Ropinirole), bariatric agents (Phentermine, Phendimetrazine), and antidepressants (Trimipramine). The core offering includes both immediate-release and extended-release solid oral dose formulations, with a strategic focus on complex dosage forms and niche products with high barriers to entry. The proprietary ART™ technology platform underlies the company's branded pipeline of abuse-deterrent opioid products, including SequestOx™ (ELI-200) which is pending FDA approval.

Differentiator

Problem solved

Functional benefit

Brands

• SequestOx (ELI-200): Opioid product under development for pain management using abuse-deterrent technology, with NDA submitted pending approval.

Products and services

• Methadone HCl Tablets Generic opiate medication for severe pain management and opioid addiction treatment available in 5 mg and 10 mg strengths, distributed under Elite Laboratories label and subject to REMS requirements.
• Ropinirole Extended-Release Tablets USP (Generic Requip XL®) Generic non-ergoline dopamine agonist for Parkinson's disease available in 2 mg, 4 mg, 6 mg, 8 mg, and 12 mg strengths; FDA approved in November 2025.
• Lisdexamfetamine Dimesylate Capsules (Vyvanse®) Generic CNS stimulant prodrug available in 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg strengths, bioequivalent to Vyvanse®.
• Naltrexone Hydrochloride Tablets (Revia®)

Quantifiable outcome

• 120% year-over-year revenue growth to $31.6M in Q3 FY2026
• +2 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• TAGI PharmaminorChannel Partner/ Reseller/ DistributorTAGI Pharma distributes certain generic products under license from Elite Pharmaceuticals. Elite owns multiple generic products, some of which are licensed to TAGI Pharma for distribution.

Scale indicators9 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• ANI Pharmaceuticals: Small-cap US specialty generics company with a portfolio focused on controlled-release, niche, and limited-competition products. Highly comparable business model to Elite's niche-generic, high-barrier-entry strategy.
• Lannett Company: US generic pharmaceutical manufacturer with emphasis on controlled-release solid oral dose products. Comparable scale and product mix to Elite's generic portfolio across CNS, cardiovascular, and pain therapeutic categories.
• Amneal Pharmaceuticals: US-based generic and specialty pharma company with significant presence in controlled-release generics, CNS stimulants (including generic Vyvanse), and complex dosage forms. Direct competitor in overlapping therapeutic categories.
• Mallinckrodt Pharmaceuticals: Specialty pharma with a generics segment and significant abuse-deterrent opioid franchise. Comparable in controlled-release opioid positioning and generic/specialty hybrid business model.
• Upsher-Smith Laboratories: Private US generic pharmaceutical manufacturer with focus on specialty generics and controlled-release formulations. Comparable niche strategy and therapeutic category overlap (CNS, cardiovascular).

Broad incumbents

• Endo Pharmaceuticals: Specialty and generics pharmaceutical company with established pain management franchise including abuse-deterrent opioids. Broader portfolio than Elite but directly comparable in generic opioid and specialty pain positioning.
• Zydus Pharmaceuticals (USA): US arm of Indian generic manufacturer offering finished dosage generics across CNS, pain, and cardiovascular. Competes with Elite in several of the same molecule categories at typically larger scale.
• Aurobindo Pharma USA: US generics subsidiary of Aurobindo Pharma with broad generic portfolio including CNS stimulants and controlled-release products. Larger-scale competitor with overlapping product categories.
• Sandoz (Novartis): Global generics leader with strong US presence in controlled-release generics and complex dosage forms. Elite's Chief Commercial Officer Kirko Kirkov previously led Sandoz commercial operations, illustrating the direct competitive overlap.
• Teva Pharmaceutical Industries: World's largest generic drug manufacturer with extensive US generics business across CNS stimulants (Adderall/Vyvanse generics) and pain management. Direct competitor to Elite's key revenue products at much larger scale.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/elitepharma

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds5 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Elite Pharmaceuticals