FDA Approves 10-Year Exclusivity for Phathom’s VOQUEZNA Tablets

FLORHAM PARK, N.J., June 06, 2025 (GLOBE NEWSWIRE) — Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT) announced today that the U.S. Food and Drug Administration (FDA) approved its Citizen Petition, confirming a full 10 years of New Chemical Entity (NCE) exclusivity for VOQUEZNA® (vonoprazan) tablets. This exclusivity extends through May 3, 2032.

VOQUEZNA is a first-in-class potassium-competitive acid blocker (PCAB) used for treating heartburn linked to Non-Erosive GERD and aiding in the healing of Erosive GERD in adults. It also includes VOQUEZNA TRIPLE PAK and DUAL PAK for combating H. pylori infections.

By correcting the Orange Book listing, the FDA ensures that no generics can enter the market for nearly seven more years, keeping Phathom’s product protected. This milestone significantly boosts Phathom’s long-term competitive position in the gastrointestinal treatment market.

“The FDA’s affirmation of a full exclusivity period for VOQUEZNA is a major win for us,” said a Phathom Pharmaceuticals representative. “It not only protects our intellectual property but also enhances our strategic position moving forward.”

Phathom Pharmaceuticals focuses on developing therapies for gastrointestinal diseases and has positioned VOQUEZNA as a key product in its portfolio. The FDA ruling allows Phathom to secure market access and better pricing power, directly impacting its growth potential in the sector.

As regulatory landscapes evolve, Phathom continues to navigate the complexities of drug approval processes in hopes of providing effective treatments while maintaining a robust business model.