---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-430621"
form_type: "8-K"
ticker: "PHAT"
cik: "0001783183"
company_name: "Phathom Pharmaceuticals, Inc."
filed_at: "2026-10-23T21:00:48+00:00"
generated_at: "2026-10-23T21:02:04.465137+00:00"
event_type: "litigation"
sentiment: "negative"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# BDR sues FDA over VOQUEZNA NCE exclusivity; Phathom defends 10-year term to May 2032

## Summary
- BDR Pharmaceuticals International Pvt. Ltd. sued FDA and related Federal Defendants in the U.S. District Court for the District of Columbia over an ANDA referencing Phathom's VOQUEZNA NDA.
- BDR alleges FDA improperly applied the GAIN Act to extend Phathom's New Chemical Entity exclusivity for VOQUEZNA (vonoprazan fumarate) tablets.
- Phathom says FDA correctly recognized 10 years of NCE exclusivity through May 3, 2032 in its June 6, 2025 grant of Phathom's December 11, 2024 Citizen Petition.
- Phathom intends to take appropriate action to protect its statutory exclusivities; it warns an adverse outcome could shorten exclusivity and allow ANDAs earlier.

## SEC filing metadata
- accession: 0001193125-26-430621
- form_type: 8-K
- ticker: PHAT
- cik: 0001783183
- company_name: Phathom Pharmaceuticals, Inc.
- filed_at: 2026-10-23T21:00:48+00:00
- event_type: litigation
- sentiment: negative
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1783183/000119312526430621/0001193125-26-430621-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1783183/000119312526430621/d437998d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-430621
- JSON: https://secwatch.observer/filing/0001193125-26-430621.json
- Plain text: https://secwatch.observer/filing/0001193125-26-430621.txt

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