---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-23-046142"
form_type: "8-K"
ticker: "ELTP"
cik: "0001053369"
company_name: "ELITE PHARMACEUTICALS INC /NV/"
filed_at: "2023-12-26T23:59:59+00:00"
generated_at: "2026-06-07T07:12:06.968430+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Elite Pharmaceuticals files ANDA for generic CNS stimulant; market $5.1B

## Summary
- ANDA accepted for review by FDA on Dec 21, 2023 for undisclosed generic CNS stimulant.
- IQVIA reports annual brand and generic market sales of $5.1B for this product (12 months to June 2023).
- Elite operates a cGMP and DEA-registered facility in Northvale, NJ for R&D and manufacturing.
- No launch timeline or revenue guidance provided; approval and commercialization still pending.

## SEC filing metadata
- accession: 0001493152-23-046142
- form_type: 8-K
- ticker: ELTP
- cik: 0001053369
- company_name: ELITE PHARMACEUTICALS INC /NV/
- filed_at: 2023-12-26T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1053369/000149315223046142/0001493152-23-046142-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1053369/000149315223046142/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-23-046142
- JSON: https://secwatch.observer/filing/0001493152-23-046142.json
- Plain text: https://secwatch.observer/filing/0001493152-23-046142.txt

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