ELITE PHARMACEUTICALS INC /NV/
ELTP evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for ELTP—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · ELTP
Elite Pharmaceuticals Inc. is a specialty pharmaceutical company focused on developing and manufacturing generic and controlled-release oral drugs, with a strategy centered on high-barrier-to-entry products and a recently launched generic methadone tablet.
Key risk: FDA approval delays
BioSniper Score
Based on 3 of 6 signals
Limited data coverage
Financial data as of Jun 30, 2026.
Tracking 1 clinical trial · 1 catalyst for ELITE PHARMACEUTICALS INC /NV/.
Elite Pharmaceuticals Inc. is a specialty pharmaceutical company focused on developing and manufacturing generic and controlled-release oral drugs, with a strategy centered on high-barrier-to-entry products and a recently launched generic methadone tablet.
- Specialty pharmaceutical company engaged in development and manufacture of oral, controlled-release products and generic pharmaceuticals [sec_mda · as of 2026-08-13].
- Commercial launch of generic methadone hydrochloride 5 mg and 10 mg tablets announced on April 2, 2026 [sec_mda · as of 2026-06-29].
- Filed an Abbreviated New Drug Application (ANDA) with the FDA on June 1, 2026 for a generic anticoagulant [sec_mda · as of 2026-06-29].
- Cash and equivalents of $39.4M, total revenue of $32.4M, and net income of $5.9M as of 2026-06-30 [sec].
- Manufacturing facility in Northvale, NJ operates under cGMP and is DEA-registered [sec_mda · as of 2026-08-13].
What works
- Revenue grew significantly, with manufacturing fees increasing 80% year-over-year to $147.8M for the fiscal year ended March 31, 2026 [sec_mda · as of 2026-06-29].
- Company is current on all NJEDA bond interest and principal payments, with no arrears as of the latest filing [sec_mda · as of 2026-06-29].
- Positive net income of $5.9M as of 2026-06-30, indicating recent profitability [sec].
- Strategy focuses on generic versions of controlled-release drugs with high barriers to entry, which can offer competitive advantages [sec_mda · as of 2026-08-13].
What to weigh
- Company relies on FDA approval of ANDAs, which involves risks and uncertainties including delays and inability to obtain necessary ingredients [sec · filed 2026-08-04].
- Research and development expenses increased by $0.4M (21%) for the three months ended June 30, 2026, driven by costs for a pivotal bioequivalence study and ANDA filing [sec_mda · as of 2026-08-13].
- Forward-looking statements caution that actual results may differ materially due to factors outside the company's control [sec · filed 2026-08-04].
From the filings
Quoted directly from source documents.
Commercial launch of generic methadone tablets in April 2026
“On April 2, 2026, we announced the commercial launch of our generic methadone hydrochloride 5 mg and 10 mg tablets.”
SEC MD&A · June 29, 2026
ANDA filed for a generic anticoagulant in June 2026
“On June 1, 2026, we filed an Abbreviated New Drug Application with the US Food and Drug Administration for a generic version of an undisclosed drug product in the class of medications called anticoagulants.”
SEC MD&A · June 29, 2026
Company description as a specialty pharmaceutical company
“We are a specialty pharmaceutical company principally engaged in the development and manufacture of oral, controlled-release products, and the manufacture of generic pharmaceuticals.”
SEC MD&A · August 13, 2026
Catalyst timeline
- 2026-11-14 · Earnings — Earnings Report: first quarter of fiscal year 2027 ended June 30, 2026 — The company will report financial results for the quarter ended June 30, 2026, providing insight into recent performance.
Risks & what to watch (3)›
Key risks
- FDA approval delays — Ability to obtain FDA approval of ANDAs is subject to delays and uncertainties [sec · filed 2026-08-04].
- Supply chain dependencies — Inability to obtain necessary ingredients could impact operations [sec · filed 2026-08-04].
- R&D expense volatility — Research and development costs fluctuate with product development activities, increasing 21% in recent quarter [sec_mda · as of 2026-08-13].
What to watch
- FDA decision on the ANDA filed June 1, 2026 for a generic anticoagulant [sec_mda · as of 2026-06-29].
- Revenue and profitability trends from the generic methadone launch and other products [sec_mda · as of 2026-06-29].
- Upcoming earnings report for the first quarter of fiscal year 2027 on November 14, 2026 [catalyst].
- Changes in research and development expenses related to ongoing product development [sec_mda · as of 2026-08-13].
Sources: Catalysts · SEC filings · SEC MD&A · Generated August 28, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 3 of 6 signals · derived from public data
No clinical pipeline tracked — this score reflects financial & catalyst signals only.
Profitable (positive operating cash flow)
D/E 0.33 · 5% dilution
No tracked pipeline phase
No tracked pipeline candidates
1 upcoming, next in ~76d
No insider transactions in the last 180 days
Catalysts
Regulatory
Financials
Frequently asked questions
What is the AI investment thesis for ELITE PHARMACEUTICALS INC /NV/?
Elite Pharmaceuticals Inc. is a specialty pharmaceutical company focused on developing and manufacturing generic and controlled-release oral drugs, with a strategy centered on high-barrier-to-entry products and a recently launched generic methadone tablet.
What is ELITE PHARMACEUTICALS INC /NV/'s next catalyst?
ELITE PHARMACEUTICALS INC /NV/'s next tracked catalyst is a Earnings event — "Earnings Report: first quarter of fiscal year 2027 ended June 30, 2026" — expected November 14, 2026.
Who is the CEO of ELITE PHARMACEUTICALS INC /NV/?
Mr. Nasrat Hakim is the chief executive officer of ELITE PHARMACEUTICALS INC /NV/ (ELTP).
Where is ELITE PHARMACEUTICALS INC /NV/ headquartered?
ELITE PHARMACEUTICALS INC /NV/ (ELTP) is headquartered in Northvale, NJ, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.