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

Phathom Pharmaceuticals, Inc.

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.

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