---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-026519"
form_type: "8-K"
ticker: "ELTP"
cik: "0001053369"
company_name: "ELITE PHARMACEUTICALS INC /NV/"
filed_at: "2026-06-01T11:00:24+00:00"
generated_at: "2026-06-01T11:06:06.952943+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Elite Pharmaceuticals files ANDA for generic anticoagulant; $26B brand market, no generic available

## Summary
- 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.

## SEC filing metadata
- accession: 0001493152-26-026519
- form_type: 8-K
- ticker: ELTP
- cik: 0001053369
- company_name: ELITE PHARMACEUTICALS INC /NV/
- filed_at: 2026-06-01T11:00:24+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1053369/000149315226026519/0001493152-26-026519-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1053369/000149315226026519/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-026519
- JSON: https://secwatch.observer/filing/0001493152-26-026519.json
- Plain text: https://secwatch.observer/filing/0001493152-26-026519.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.