Phathom Pharmaceuticals Submits Citizen Petition to FDA for Correction of Orange Book Listings for VOQUEZNA Tablets

Phathom Pharmaceuticals, Inc. announced in an 8-K filing on December 11, 2024, that it has submitted a Citizen Petition (CP) to the U.S. Food and Drug Administration (FDA) seeking the correction of the Orange Book listings for VOQUEZNA (vonoprazan) 10 mg and 20 mg tablets. The petition aims to accurately reflect the full 10-year New Chemical Entity (NCE) exclusivity period until May 3, 2032.

The requested update aligns the Orange Book listings for VOQUEZNA tablets with the NCE exclusivity period granted upon the approval of vonoprazan-based VOQUEZNA TRIPLE PAK® and VOQUEZNA DUAL PAK® in May 2022. This statutory 10-year exclusivity period includes the standard five-year exclusivity for NCEs, extended by an additional five years through the Generating Antibiotic Incentives Now (GAIN) Act due to the presence of the same active moiety, vonoprazan, in all products.

Phathom’s Citizen Petition highlights key aspects, such as the significance of New Chemical Entity Exclusivity Provisions, the application of the GAIN Act in extending the NCE exclusivity to vonoprazan-containing products, and the company’s call for the FDA to promptly adjust the Orange Book to reflect the correct NCE exclusivity period ending on May 3, 2032.

The FDA is expected to respond within 180 days of receiving the petition. This response may involve approval, denial, dismissal, or a tentative response explaining any delays in decision-making. Phathom views the CP as an opportunity for the FDA to evaluate the request within a defined framework and formalize its decision in accordance with regulatory procedures.

The company cautions investors against undue reliance on forward-looking statements included in the report, emphasizing uncertainties surrounding FDA decisions, potential extension of NCE exclusivity to VOQUEZNA tablets, and the expected duration of patent term extension. Phathom underscores that actual outcomes may vary due to inherent business risks and uncertainties, including regulatory approvals, intellectual property protection, and competitive landscapes.

Phathom Pharmaceuticals reiterates its commitment to providing updates on this matter as developments unfold, as mandated by securities regulations.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Phathom Pharmaceuticals’s 8K filing here.

About Phathom Pharmaceuticals

Phathom Pharmaceuticals, Inc, biopharmaceutical company, focuses on developing and commercializing treatments for gastrointestinal diseases. The company has the rights in the United States, Europe, and Canada for an investigational potassium-competitive acid blocker (P-CAB) that blocks acid secretion in the stomach.