---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-001607"
form_type: "8-K"
ticker: "JAZZ"
cik: "0001232524"
company_name: "Jazz Pharmaceuticals plc"
filed_at: "2023-01-04T23:59:59+00:00"
generated_at: "2026-06-20T20:11:01.480637+00:00"
event_type: "litigation"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Jazz Pharmaceuticals sues 10 generic filers over Epidiolex patents; seeks 30-month stay

## Summary
- 10 ANDA filers, including Teva, Padagis, Apotex, Lupin, Taro, and others, filed paragraph IV certifications for generic Epidiolex.
- Jazz filed patent infringement suit on January 3, 2023 in District of New Jersey.
- Lawsuit seeks FDA approval no earlier than expiration of last asserted patent; triggers automatic 30-month stay.
- Epidiolex has Orphan Drug Exclusivity for LGS/Dravet through Sept 2025 (ages 2+) and July 2027 (ages 1-2 and TSC).
- No other ANDA filers identified as of filing date.

## SEC filing metadata
- accession: 0001193125-23-001607
- form_type: 8-K
- ticker: JAZZ
- cik: 0001232524
- company_name: Jazz Pharmaceuticals plc
- filed_at: 2023-01-04T23:59:59+00:00
- event_type: litigation
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1232524/000119312523001607/0001193125-23-001607-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1232524/000119312523001607/d428802d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-001607
- JSON: https://secwatch.observer/filing/0001193125-23-001607.json
- Plain text: https://secwatch.observer/filing/0001193125-23-001607.txt

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