ELITE PHARMACEUTICALS INC /NV/
ELTP evidence brief
What we can confirm
- BioSniper Score:
- 7.7 / 10
- Market Cap:
- $280.1M
- Next Catalyst:
- Earnings · Nov 14, 2026
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 /NV/ (ELTP) is a specialty pharmaceutical company focused on developing and manufacturing oral controlled-release and generic drug products, with a strategy centered on high-barrier-to-entry generics and a growing product portfolio.
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 /NV/ (ELTP) is a specialty pharmaceutical company focused on developing and manufacturing oral controlled-release and generic drug products, with a strategy centered on high-barrier-to-entry generics and a growing product portfolio.
- Total revenue of $32.4M and net income of $5.9M as of 2026-06-30 [sec].
- Shareholders' equity of $104.8M as of 2026-06-30 [sec].
- 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 ANDA for a generic anticoagulant on June 1, 2026 [sec_mda · as of 2026-06-29].
- Launched generic Requip XL (Ropinirole ER Tablets) on August 4, 2026 [news · published 2026-08-04].
What works
- Record fiscal 2026 earnings with stronger profits and improved cash flow [news · published 2026-07-03].
- Expanding generic product portfolio with recent launches of methadone tablets and ropinirole ER tablets [sec_mda · as of 2026-06-29] [news · published 2026-08-04].
- Positive results from a pivotal bioequivalence study for an undisclosed anticonvulsant generic, addressing a market with $840M in sales [news · published 2026-06-15].
What to weigh
- Forward-looking statements caution about risks including FDA approval delays and ingredient availability [sec · filed 2026-08-04].
- Market pricing pressures are noted as a challenge [news · published 2026-08-18].
- The company is currently listed on OTCQB and is pursuing a Nasdaq uplisting, which may involve additional regulatory and market hurdles [news · published 2026-08-18].
From the filings
Quoted directly from source documents.
Elite is a specialty pharmaceutical company focused on oral controlled-release and generic products.
“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
Elite launched generic methadone hydrochloride 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
Elite filed an ANDA 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
Catalyst timeline
- 2026-11-14 · Earnings — Regulation FD Disclosure — Elite issued a press release on August 10, 2026, announcing financial results; the catalyst date reflects the earnings disclosure event.
Risks & what to watch (3)›
Key risks
- FDA approval delays — Forward-looking statements note risks including inability to obtain FDA approval or delays in the approval process [sec · filed 2026-08-04].
- Market pricing pressures — Q1 FY2027 earnings call highlights navigating market pricing pressures [news · published 2026-08-18].
- Dependence on ANDA approvals — Business strategy relies on ANDA approvals; any delay or denial impacts product launches [sec_mda · as of 2026-08-13].
What to watch
- FDA decision on the ANDA for the generic anticoagulant filed June 1, 2026 [sec_mda · as of 2026-06-29].
- Progress on Nasdaq uplisting plans mentioned in Q1 FY2027 earnings call [news · published 2026-08-18].
- Commercial performance of recently launched generic methadone and ropinirole ER tablets [sec_mda · as of 2026-06-29] [news · published 2026-08-04].
- Outcome of the pivotal bioequivalence study for the anticonvulsant generic and subsequent ANDA filing [news · published 2026-06-15].
Sources: News · SEC filings · SEC MD&A · Generated October 8, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 3 of 6 signals · derived from public data
Pipeline inputs are unavailable for this score. It uses only the available signals shown below.
Profitable (positive operating cash flow)
D/E 0.33 · 5% dilution
No tracked pipeline phase
No tracked pipeline candidates
1 upcoming, next in ~31d
No insider transactions in the last 180 days
Catalysts
Regulatory
Financials
Governance
Frequently asked questions
What is the AI investment thesis for ELITE PHARMACEUTICALS INC /NV/?
Elite Pharmaceuticals Inc /NV/ (ELTP) is a specialty pharmaceutical company focused on developing and manufacturing oral controlled-release and generic drug products, with a strategy centered on high-barrier-to-entry generics and a growing product portfolio.
What is ELITE PHARMACEUTICALS INC /NV/'s next catalyst?
ELITE PHARMACEUTICALS INC /NV/'s next tracked catalyst is a Earnings event — "Earnings: Regulation FD Disclosure.: August 10, 2026, Elite Pharmaceuticals, Inc. ("Elite" or the "Company") issued a press release announcing that" — 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.