---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-274876"
form_type: "8-K"
ticker: "PHAT"
cik: "0001783183"
company_name: "Phathom Pharmaceuticals, Inc."
filed_at: "2024-12-11T23:59:59+00:00"
generated_at: "2026-05-29T04:46:00.986118+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Phathom files Citizen Petition to correct VOQUEZNA Orange Book exclusivity to May 2032

## Summary
- Petition requests FDA correct VOQUEZNA tablet listings to reflect 10-year NCE exclusivity ending May 3, 2032.
- Exclusivity stems from GAIN Act extension on vonoprazan, already applied to VOQUEZNA DUAL/TRIPLE PAK approved May 2022.
- FDA must respond within 180 days; may approve, deny, or provide tentative response.
- Corrected listing would block ANDA or 505(b)(2) submissions referencing vonoprazan until expiry.
- Phathom expects CP docket to appear on regulations.gov in coming days.

## SEC filing metadata
- accession: 0001193125-24-274876
- form_type: 8-K
- ticker: PHAT
- cik: 0001783183
- company_name: Phathom Pharmaceuticals, Inc.
- filed_at: 2024-12-11T23:59:59+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/1783183/000119312524274876/0001193125-24-274876-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1783183/000119312524274876/d904037d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-274876
- JSON: https://secwatch.observer/filing/0001193125-24-274876.json
- Plain text: https://secwatch.observer/filing/0001193125-24-274876.txt

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