---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-141119"
form_type: "8-K"
ticker: "PHAT"
cik: "0001783183"
company_name: "Phathom Pharmaceuticals, Inc."
filed_at: "2025-06-16T23:59:59+00:00"
generated_at: "2026-05-19T06:40:18.447607+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA Orange Book corrected; VOQUEZNA NCE exclusivity confirmed through May 2032

## Summary
- FDA updated Orange Book to show full 10-year NCE exclusivity for VOQUEZNA (vonoprazan) 10 mg and 20 mg tablets.
- Corrected listing confirms exclusivity runs through May 3, 2032, aligning with statutory requirements.
- Phathom says this reinforces the long-term commercial runway for its first-in-class product.
- NCE exclusivity prevents generic competition for the full 10-year period from approval date.

## SEC filing metadata
- accession: 0001193125-25-141119
- form_type: 8-K
- ticker: PHAT
- cik: 0001783183
- company_name: Phathom Pharmaceuticals, Inc.
- filed_at: 2025-06-16T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1783183/000119312525141119/0001193125-25-141119-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1783183/000119312525141119/d924090d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-141119
- JSON: https://secwatch.observer/filing/0001193125-25-141119.json
- Plain text: https://secwatch.observer/filing/0001193125-25-141119.txt

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