---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-22-029261"
form_type: "8-K"
ticker: "PBYI"
cik: "0001401667"
company_name: "PUMA BIOTECHNOLOGY, INC."
filed_at: "2022-12-16T23:59:59+00:00"
generated_at: "2026-06-21T03:13:08.356818+00:00"
event_type: "litigation"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Puma settles Neratinib patent litigation with Sandoz; generic entry allowed Dec 2030

## Summary
- Settlement and License Agreement with Sandoz fully resolves pending Hatch-Waxman litigation in New Jersey.
- Sandoz receives a non-exclusive, royalty-free sublicense to key patents, including U.S. Patent No. 7,399,865 B2.
- Sandoz may begin selling generic Neratinib on or about December 8, 2030, subject to adjustment.
- Company and Wyeth also grant Sandoz a waiver of all regulatory exclusivities.
- Settlement eliminates burden, expense, and uncertainties of further litigation.

## SEC filing metadata
- accession: 0001437749-22-029261
- form_type: 8-K
- ticker: PBYI
- cik: 0001401667
- company_name: PUMA BIOTECHNOLOGY, INC.
- filed_at: 2022-12-16T23:59:59+00:00
- event_type: litigation
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1401667/000143774922029261/0001437749-22-029261-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1401667/000143774922029261/pbyi20221216_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-22-029261
- JSON: https://secwatch.observer/filing/0001437749-22-029261.json
- Plain text: https://secwatch.observer/filing/0001437749-22-029261.txt

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