secwatch.observer — SEC 8-K summary
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Issuer:     Jazz Pharmaceuticals plc (JAZZ)
CIK:        0001232524
Form:       8-K
Filed at:   2023-01-04T23:59:59+00:00
Accession:  0001193125-23-001607
Event type: litigation
Sentiment:  negative
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1232524/000119312523001607/0001193125-23-001607-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1232524/000119312523001607/d428802d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-001607

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