---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-046525"
form_type: "8-K"
ticker: "ELTP"
cik: "0001053369"
company_name: "ELITE PHARMACEUTICALS INC /NV/"
filed_at: "2024-11-18T23:59:59+00:00"
generated_at: "2026-05-29T22:52:59.560886+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Elite Pharma gets FDA nod for generic Vyvanse; $4.3B market

## Summary
- Received FDA approval on November 15, 2024 for ANDA for generic Lisdexamfetamine Dimesylate (Vyvanse) in 7 strengths (10-70 mg capsules).
- Product indicated for ADHD; marketed under Elite Laboratories label.
- IQVIA reported annual sales of $4.3B for brand and generic market (12 months ending September 2024).

## SEC filing metadata
- accession: 0001493152-24-046525
- form_type: 8-K
- ticker: ELTP
- cik: 0001053369
- company_name: ELITE PHARMACEUTICALS INC /NV/
- filed_at: 2024-11-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1053369/000149315224046525/0001493152-24-046525-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1053369/000149315224046525/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-046525
- JSON: https://secwatch.observer/filing/0001493152-24-046525.json
- Plain text: https://secwatch.observer/filing/0001493152-24-046525.txt

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