---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-020707"
form_type: "8-K"
ticker: "ELTP"
cik: "0001053369"
company_name: "ELITE PHARMACEUTICALS INC /NV/"
filed_at: "2024-05-20T23:59:59+00:00"
generated_at: "2026-06-01T12:09:04.270844+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Elite Pharma receives FDA approval for generic Methotrexate; market $64.3M annual sales

## Summary
- FDA approved ANDA for generic Methotrexate Sodium 2.5 mg tablets on May 16, 2024.
- Product will be marketed under Elite Laboratories, Inc. label.
- IQVIA reports $64.3 million in annual U.S. generic market sales (12 months ending Mar 2024).

## SEC filing metadata
- accession: 0001493152-24-020707
- form_type: 8-K
- ticker: ELTP
- cik: 0001053369
- company_name: ELITE PHARMACEUTICALS INC /NV/
- filed_at: 2024-05-20T23:59:59+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/1053369/000149315224020707/0001493152-24-020707-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1053369/000149315224020707/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-020707
- JSON: https://secwatch.observer/filing/0001493152-24-020707.json
- Plain text: https://secwatch.observer/filing/0001493152-24-020707.txt

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