---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-23-016220"
form_type: "8-K"
ticker: "HRMY"
cik: "0001802665"
company_name: "Harmony Biosciences Holdings, Inc."
filed_at: "2023-10-04T23:59:59+00:00"
generated_at: "2026-06-10T04:55:10.001570+00:00"
event_type: "litigation"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Harmony Biosciences receives generic challenge notices for WAKIX from Novugen and Lupin

## Summary
- Novugen Pharma and Lupin Ltd. filed ANDAs seeking FDA approval to market generic pitolisant (WAKIX) before patent expiry.
- Paragraph IV notices challenge U.S. Patents 8,486,947 & 8,207,197, expiring Sept 2029 and Mar 2030 respectively.
- Patent 8,354,430 (expiring Feb 2026) is not challenged in the notices.
- Company states it will vigorously defend its intellectual property rights for WAKIX.

## SEC filing metadata
- accession: 0001558370-23-016220
- form_type: 8-K
- ticker: HRMY
- cik: 0001802665
- company_name: Harmony Biosciences Holdings, Inc.
- filed_at: 2023-10-04T23:59:59+00:00
- event_type: litigation
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1802665/000155837023016220/0001558370-23-016220-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1802665/000155837023016220/hrmy-20230928x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-23-016220
- JSON: https://secwatch.observer/filing/0001558370-23-016220.json
- Plain text: https://secwatch.observer/filing/0001558370-23-016220.txt

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