---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-008450"
form_type: "8-K"
ticker: "FENC"
cik: "0001211583"
company_name: "FENNEC PHARMACEUTICALS INC."
filed_at: "2023-01-31T23:59:59+00:00"
generated_at: "2026-06-20T05:01:46.641841+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Fennec receives FDA Orphan Drug Exclusivity for PEDMARK; 7-year market exclusivity until 2029

## Summary
- FDA granted Orphan Drug Exclusivity to PEDMARK, providing 7-year market exclusivity from Sept. 20, 2022 to Sept. 20, 2029.
- PEDMARK is the first and only FDA-approved therapy to reduce cisplatin-induced ototoxicity in pediatric solid tumor patients.
- Company holds three Orange Book patents for PEDMARK, with protection until 2038-2039.
- FDA explicitly directed that PEDMARK is not substitutable with other sodium thiosulfate products.

## SEC filing metadata
- accession: 0001104659-23-008450
- form_type: 8-K
- ticker: FENC
- cik: 0001211583
- company_name: FENNEC PHARMACEUTICALS INC.
- filed_at: 2023-01-31T23:59:59+00:00
- event_type: regulatory
- 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/1211583/000110465923008450/0001104659-23-008450-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1211583/000110465923008450/tm235024d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-008450
- JSON: https://secwatch.observer/filing/0001104659-23-008450.json
- Plain text: https://secwatch.observer/filing/0001104659-23-008450.txt

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