---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-137094"
form_type: "8-K"
ticker: "PHAT"
cik: "0001783183"
company_name: "Phathom Pharmaceuticals, Inc."
filed_at: "2025-06-06T23:59:59+00:00"
generated_at: "2026-05-19T18:31:20.227391+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA grants Phathom citizen petition; VOQUEZNA exclusivity extended to May 2032

## Summary
- FDA approved Phathom's 2024 citizen petition to correct Orange Book for VOQUEZNA (vonoprazan) tablets.
- VOQUEZNA will benefit from the 10-year NCE*GAIN exclusivity originally awarded to VOQUEZNA Triple Pak and Dual Pak.
- FDA will update Orange Book to reflect exclusivity extending through May 3, 2032 (previously May 3, 2027).
- Decision protects VOQUEZNA from generic competition for an additional 5 years under FDA's umbrella policy.
- VOQUEZNA was not itself designated as a QIDP, but the exclusivity attaches to the active moiety vonoprazan.

## SEC filing metadata
- accession: 0001193125-25-137094
- form_type: 8-K
- ticker: PHAT
- cik: 0001783183
- company_name: Phathom Pharmaceuticals, Inc.
- filed_at: 2025-06-06T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1783183/000119312525137094/0001193125-25-137094-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1783183/000119312525137094/d941196d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-137094
- JSON: https://secwatch.observer/filing/0001193125-25-137094.json
- Plain text: https://secwatch.observer/filing/0001193125-25-137094.txt

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