---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-23-033590"
form_type: "8-K"
ticker: "ELTP"
cik: "0001053369"
company_name: "ELITE PHARMACEUTICALS INC /NV/"
filed_at: "2023-09-25T23:59:59+00:00"
generated_at: "2026-06-10T09:07:17.654585+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 opiate analgesic with $720M market

## Summary
- Filed ANDA with FDA on August 17, 2023 for a generic opiate analgesic product.
- FDA accepted the ANDA for review on September 19, 2023.
- IQVIA reported $720 million in annual brand and generic sales for this product (12 months ending June 2023).
- The specific drug product remains undisclosed.

## SEC filing metadata
- accession: 0001493152-23-033590
- form_type: 8-K
- ticker: ELTP
- cik: 0001053369
- company_name: ELITE PHARMACEUTICALS INC /NV/
- filed_at: 2023-09-25T23:59:59+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/1053369/000149315223033590/0001493152-23-033590-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1053369/000149315223033590/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-23-033590
- JSON: https://secwatch.observer/filing/0001493152-23-033590.json
- Plain text: https://secwatch.observer/filing/0001493152-23-033590.txt

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