8-K
filed June 1, 2026, 7:00 AM ET
ticker ELTP
CIK 0001053369
regulatory
confidence high
sentiment positive
materiality 0.65
Elite Pharmaceuticals files ANDA for generic anticoagulant; $26B brand market, no generic available
ELITE PHARMACEUTICALS INC /NV/
- ANDA submitted to FDA for generic version of an undisclosed anticoagulant drug product.
- IQVIA reports branded product sales of $26 billion for twelve months ending March 2026.
- No generic product currently on market; brand has unexpired patents and exclusivity in FDA Orange Book.
- FDA approval and commercialization subject to successful filing, approval, and addressing patents.
- Elite expands pipeline into high-value anticoagulant market; no timeline for launch provided.
Machine-readable event card
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- secwatch.filing_event.v1
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- 0001493152-26-026519
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- cik
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- company_name
- ELITE PHARMACEUTICALS INC /NV/
- filed_at
- 2026-06-01T11:00:24+00:00
- discovered_at
- 2026-06-01T11:05:00.291444+00:00
- generated_at
- 2026-06-01T11:06:06.952943+00:00
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- ["7.01", "9.01"]
- event_type
- regulatory
- sentiment
- positive
- materiality_score
- 0.65
- calibrated_materiality_score
- 0.65
- confidence
- high
- secwatch_canonical_url
- https://secwatch.observer/filing/0001493152-26-026519
- json_url
- https://secwatch.observer/filing/0001493152-26-026519.json
- markdown_url
- https://secwatch.observer/filing/0001493152-26-026519.md
- text_url
- https://secwatch.observer/filing/0001493152-26-026519.txt
- edgar_index_url
- https://www.sec.gov/Archives/edgar/data/1053369/000149315226026519/0001493152-26-026519-index.htm
- edgar_primary_document_url
- https://www.sec.gov/Archives/edgar/data/1053369/000149315226026519/form8-k.htm
- generated_by_model
- deepseek-v4-flash:cloud@v2
- review_status
- machine_generated
- human_reviewed
- false
- corrected
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- correction_timestamp
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