---
schema_version: "secwatch.filing_event.v1"
accession: "0001641172-25-015172"
form_type: "8-K"
ticker: "ELTP"
cik: "0001053369"
company_name: "ELITE PHARMACEUTICALS INC /NV/"
filed_at: "2025-06-16T23:59:59+00:00"
generated_at: "2026-05-19T05:58:43.677040+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Elite Pharma reports positive bioequivalence study for undisclosed anticoagulant generic; brand sales $27B

## Summary
- Positive pivotal bioequivalence results for an undisclosed generic anticoagulant; product is bioequivalent to brand.
- Branded product sales $27B (12 months ending April 2025); no generic marketed; unexpired Orange Book patent exists.
- Elite will compile data to file ANDA with FDA; commercialization conditional on FDA approval and patent resolution.

## SEC filing metadata
- accession: 0001641172-25-015172
- form_type: 8-K
- ticker: ELTP
- cik: 0001053369
- company_name: ELITE PHARMACEUTICALS INC /NV/
- filed_at: 2025-06-16T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1053369/000164117225015172/0001641172-25-015172-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1053369/000164117225015172/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001641172-25-015172
- JSON: https://secwatch.observer/filing/0001641172-25-015172.json
- Plain text: https://secwatch.observer/filing/0001641172-25-015172.txt

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