Phathom Pharmaceuticals Announces Positive FDA Decision to Recognize 10 Years of Regulatory Exclusivity for VOQUEZNA® (vonoprazan) Tablets through May 3, 2032
- FDA grants 10-year regulatory exclusivity for VOQUEZNA through May 2032, protecting from generic competition
- Extended market protection for multiple approved indications including GERD and H. pylori treatment
- Strengthened intellectual property position for their first-in-class PCAB drug
- Potential competition after 2032 when exclusivity expires
- Success still depends on market acceptance and insurance coverage
- Company faces risks related to unexpected side effects and regulatory developments
Insights
FDA grants VOQUEZNA 10-year market exclusivity through 2032, significantly enhancing Phathom's competitive position and long-term revenue potential.
The FDA's decision to approve Phathom's Citizen Petition and correct the Orange Book to recognize the full 10 years of New Chemical Entity (NCE) exclusivity for VOQUEZNA® (vonoprazan) is a major regulatory win for the company. This extends protection through May 3, 2032, effectively blocking generic competition for nearly seven more years.
NCE exclusivity represents the strongest form of non-patent regulatory protection available. This designation prevents the FDA from accepting abbreviated new drug applications (ANDAs) for generic versions of vonoprazan, regardless of patent status. For Phathom, this translates to protected market access and pricing power for their flagship product.
VOQUEZNA's positioning as a first-in-class potassium-competitive acid blocker (PCAB) for gastrointestinal diseases represents a novel mechanism of action in the U.S. market. The drug's approved indications span substantial markets including non-erosive GERD, erosive GERD, and H. pylori infection treatment (via VOQUEZNA TRIPLE PAK and DUAL PAK).
The language regarding the "proper" 10 years of exclusivity suggests this was a correction of an earlier Orange Book listing that didn't reflect the full exclusivity period Phathom was entitled to. The successful petition demonstrates effective regulatory affairs capabilities and protects a critical asset in the company's portfolio.
This regulatory milestone significantly enhances Phathom's commercial runway for VOQUEZNA, providing certainty for both near and medium-term business planning while strengthening the company's position with potential partners, payers, and investors.
FLORHAM PARK, N.J., June 06, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT) today announced that the U.S. Food and Drug Administration (FDA) has approved Phathom’s Citizen Petition filed on December 11, 2024 and communicated the Agency’s intention to correct the Orange Book to recognize the proper 10 years of New Chemical Entity exclusivity for VOQUEZNA® (vonoprazan) tablets, extending through May 3, 2032.
About Phathom Pharmaceuticals, Inc.
Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB) that is currently marketed in the United States as VOQUEZNA® (vonoprazan) tablets for the relief of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing of Erosive GERD in adults and relief of associated heartburn, in addition to VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. For more information about Phathom, visit the company’s website at www.phathompharma.com and follow on LinkedIn and X.
Forward-Looking Statements
This press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about Phathom’s commercialization plans. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Phathom’s business, including, without limitation: the timing of the correction to the Orange Book; the expected duration of patent term extension for VOQUEZNA; we may not be able to successfully commercialize VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, which will depend on a number of factors including coverage and reimbursement levels from governmental authorities and health insurers as well as market acceptance by healthcare providers; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Phathom’s ability to obtain and maintain intellectual property protection, including patent term extensions, and non-patent regulatory exclusivity for vonoprazan; Phathom may face competition earlier than expected if it loses or fails to obtain any of its patent protection or non-patent regulatory exclusivity for VOQUEZNA tablets; Phathom’s ability to obtain and maintain intellectual property protection and non-patent regulatory exclusivity for vonoprazan; and other risks described in the Company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
MEDIA CONTACT
Nick Benedetto
1-877-742-8466
media@phathompharma.com
INVESTOR CONTACT
Eric Sciorilli
1-877-742-8466
ir@phathompharma.com
© 2025 Phathom Pharmaceuticals. All rights reserved.
VOQUEZNA, VOQUEZNA DUAL PAK, VOQUEZNA TRIPLE PAK, Phathom Pharmaceuticals, and their respective logos are registered trademarks of Phathom Pharmaceuticals, Inc.
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