Phathom Pharmaceuticals announces a positive decision of the FDA to recognize 10 years of regulatory exclusivity for VOQUEZNA® tablets (vonoprazan) until May 3, 2032
Florham Park, NJ, June 06, 2025 (Globe Newswire) – Phathom Pharmaceuticals, Inc. (Nasdaq: Phat) announced today that the Food and Drug Administration of the United States (FDA) approved the civic petition of Phathom on December 11, 2024 and communicated the intention of the agency to correct the orange book to recognize the 10 years appropriate excess® (Vonoprazan) tablets, extending until May 3, 2032.
About Phathom Pharmaceuticals, Inc.
Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and marketing of new treatments for gastrointestinal diseases. Phathom dismissed the exclusive rights of Vonoprazan, a first acid blocker (PCAB) of first order in class as Voquezna® (Vonoprazan) Compressed for the relief of stomach burns associated with non -erosive GERD in adults, healing and maintaining healing of RGC erosive in adults and relief of associated stomach burns, in addition to VOQUEZNA® Triple Pak® (Vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and Voquezna® Double pak® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori Infection in adults. For more information on Phathom, visit the company’s website at www.phathompharma.com and follow LinkedIn and X.
Prospective declarations
This press release contains prospective instructions. Investors are warned not to rely excessively to these prospective declarations, including reports on the marketing plans of Phathom. The inclusion of prospective declarations should not be considered as a representation by phathom that one of its plans will be carried out. The real results may differ from those stated in this press release due to the risks and uncertainty inherent in phathom activities, including, without limitation: the moment of the correction of the orange book; The expected duration of the extension of the term patent for Voquezna; We may not be able to successfully market Voquezna, Voquezna Triple Pak and Voquezna Dual Pak, which will depend on a number of factors, including the levels of coverage and reimbursement of government authorities and health insurers as well as the acceptance of the market by health care providers; regulatory developments in the United States and foreign countries; Undatched undesirable side effects or inadequate effectiveness of Vonoprazan which can limit its development, regulatory approval and / or marketing, or can cause reminders or allegations of responsibility for product responsibility; Phathom’s ability to obtain and maintain the protection of intellectual property, in particular extensions of patented terms and non -patient regulatory exclusivity for Vonoprazan; The phathom can face competition earlier than expected if it loses or cannot obtain any of its protection against patents or non -patient regulatory exclusivity for Voquezna tablets; Phathom’s ability to obtain and maintain the protection of intellectual property and non -patient regulatory exclusivity for Vonoprazan; and other risks described in the company’s previous press releases and the documents filed by the company with the Securities and Exchange Commission (SEC), including under the “Risk factors” section in the company’s latest annual report on Form 10-K and any subsequent file with the SEC. You are notified not to rely excessively to these prospective declarations, which only speak of these date, and Phathom takes no obligation to update these declarations to reflect events that occur or the circumstances that exist after the date of these. All prospective declarations are qualified in their entirety by this declaration, which is made under the provisions of the reform of the private security dispute.
