---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-25-008415"
form_type: "8-K"
ticker: "HRMY"
cik: "0001802665"
company_name: "Harmony Biosciences Holdings, Inc."
filed_at: "2025-06-05T23:59:59+00:00"
generated_at: "2026-05-19T22:30:23.449718+00:00"
event_type: "litigation"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Harmony settles Lupin ANDA litigation; generic WAKIX entry delayed to 2030

## Summary
- Lupin receives license to launch generic WAKIX no earlier than January 2030 (July 2030 with pediatric exclusivity).
- Litigation in U.S. District Court for Delaware dismissed as part of the agreement.
- Harmony will continue patent infringement litigation against other ANDA filers seeking generic WAKIX.
- U.S. Patent Office PTAB previously declined to institute reexamination of Harmony's polymorph patent, affirming its validity.
- Harmony is developing next-generation pitolisant formulations with patents extending potential exclusivity to 2044.

## SEC filing metadata
- accession: 0001558370-25-008415
- form_type: 8-K
- ticker: HRMY
- cik: 0001802665
- company_name: Harmony Biosciences Holdings, Inc.
- filed_at: 2025-06-05T23:59:59+00:00
- event_type: litigation
- sentiment: positive
- 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/1802665/000155837025008415/0001558370-25-008415-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1802665/000155837025008415/hrmy-20250605x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-25-008415
- JSON: https://secwatch.observer/filing/0001558370-25-008415.json
- Plain text: https://secwatch.observer/filing/0001558370-25-008415.txt

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