Phathom Seeks FDA Exclusivity Update

Phathom Pharmaceuticals has filed a Citizen Petition with the FDA to update the Orange Book listings for VOQUEZNA (vonoprazan) tablets, requesting recognition of a full 10-year New Chemical Entity (NCE) exclusivity period ending on May 3, 2032. This exclusivity was initially granted to VOQUEZNA TRIPLE PAK® and DUAL PAK® upon approval in May 2022, under the provisions of the GAIN Act.

The petition argues that VOQUEZNA tablets, containing the same active moiety, vonoprazan, should share the same exclusivity period. Phathom emphasizes that the FDA's established policies and statutory mandates support this correction.

If approved, the updated exclusivity would preclude competing applications referencing vonoprazan until 2032, bolstering the product's market position. Phathom anticipates a formal FDA response within 180 days, highlighting the importance of this adjustment for regulatory consistency and intellectual property protection.