Phathom Pharmaceuticals Provides Update on FDA Litigation
Key Highlights
- ➤FDA opened public docket on VOQUEZNA exclusivity issues, with comments due November 23, 2026
- ➤VOQUEZNA retains claimed NCE exclusivity through May 3, 2032, pending FDA litigation
- ➤Phathom moved to intervene in BDR’s lawsuit challenging FDA’s ANDA rejection
- ➤Saba Ilac intends to seek consolidation of its related litigation with BDR’s case
Expert Statements
Steve Basta, President and Chief Executive Officer of Phathom Pharmaceuticals
“FDA carefully reviewed the NCE exclusivity period applicable to VOQUEZNA through a full public process, and we believe reached the right decision”
Steve Basta, President and Chief Executive Officer of Phathom Pharmaceuticals
“We will make that case clearly in our comments to FDA and in any appropriate court proceeding, and our team remains focused on bringing VOQUEZNA to patients”
FLORHAM PARK, N.J., Oct. 26, 2026 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on commercializing and developing novel treatments for gastrointestinal (GI) diseases, today announced the U.S. Food and Drug Administration’s (FDA’s) establishment of a public docket (Docket No. FDA-2026-N-13038) to solicit comment on legal and regulatory questions regarding certain issues raised by a filer of an abbreviated new drug application (ANDA) referencing VOQUEZNA® (vonoprazan) tablets, BDR Pharmaceuticals, International Pvt. Ltd. (BDR), in litigation brought against the FDA following FDA’s rejection of the ANDA. The litigation was brought to challenge FDA’s June 6, 2025 decision granting Phathom’s Citizen Petition, which agreed with Phathom that VOQUEZNA benefits from 10 years of New Chemical Entity (NCE) exclusivity through May 3, 2032. The deadline for comments submitted to the public docket is November 23, 2026.
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