ELTP ELITE PHARMACEUTICALS INC /NV/

NEUTRAL Impact: 4/10 8-K
Horizon months Filed Jun 1, 2026 Processed 11d 22h ago SEC 0001493152-26-026519
8-K context-dependent: Items 7.01
Latest settled — T+5d
ELTP ▲ +8.33% at T+5d
NEUTRAL call ✓ call won +8.33% · α vs SPY +11.08% · entry $0.3600 → $0.3900
Next anchor: T+20d in 17d
Currently $0.3400 · -5.56% from $0.3600 entry
Entry anchored
Jun 1, 2026
via day open
T+1d
+11.11%
call +11.11% · α +10.97%
$0.4000
settled 11d ago
T+5d
+8.33%
call +8.33% · α +11.08%
$0.3900
settled 5d ago
T+20d
call — · α —
in 17d
T+60d
call — · α —
in 2mo

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Executive Summary

Elite Pharmaceuticals announced it filed an Abbreviated New Drug Application (ANDA) with the FDA for a generic anticoagulant drug. The branded product has $26 billion in trailing twelve-month sales (IQVIA data) with no generic currently on the market, but the brand has unexpired patents and exclusivities that must be addressed before approval. This is an early-stage regulatory milestone with no guaranteed approval timeline or commercial outcome.

Actionable Insight

This is an early-stage pipeline event with no approval timeline or revenue guidance. Monitor for FDA acceptance of the ANDA, patent challenge updates, and any subsequent partnership or financing announcements. No immediate trading catalyst without further regulatory clarity.

Key Facts

  • Elite filed an ANDA for a generic version of an undisclosed anticoagulant drug
  • Branded product sales were $26 billion for the twelve months ending March 2026 per IQVIA
  • No generic product is currently on the market for this drug
  • The brand has unexpired patents and exclusivities listed in the FDA Orange Book
  • FDA approval and commercialization depend on successful filing, FDA approval, and addressing patents/exclusivities

Financial Impact

No financial figures provided beyond the $26 billion branded market size; Elite's revenue, costs, and potential market share are not disclosed

revenuedilution

Risk Factors

  • FDA may not accept or approve the ANDA
  • Unexpired brand patents and exclusivities could block launch for years or require costly litigation
  • Elite may need additional capital to fund development and commercialization
  • Generic anticoagulant market may face pricing pressure and competition

Market Snapshot

Exchange
OTC
Sector
Pharmaceutical Preparations

Documents Analyzed

This report is based on 5 SEC documents filed with EDGAR.

DocumentAccession Number
8-K Filing (Primary)0001493152-26-026519
Exhibit: ex99-1.htm0001493152-26-026519
Document: 0001493152-26-026519-index-headers.html0001493152-26-026519
Document: 0001493152-26-026519-index.html0001493152-26-026519
Document: 0001493152-26-026519.txt0001493152-26-026519
2 reports for ELTP
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Jun 1, 2026
11d ago
8-K
NEUTRAL ★ 4/10
$0.3600 $0.3900▲ +8.33%▲ +11.08%$0.3400 (−5.56%)
Apr 2, 2026
10w ago
8-K
NEUTRAL ★ 4/10
$0.3800 $0.3800· 0.00%▼ −3.62%$0.3400 (−10.53%)
Showing 2 of 2

US Market Status

Market Closed — Opens Mon (52h 14m)

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