Phathom Pharmaceuticals Announces FDA Correction to Orange Book Listing, Confirming 10 Years of Regulatory Exclusivity for VOQUEZNA® (vonoprazan) Tablets Through May 3, 2032

Rhea-AI Summary

Phathom Pharmaceuticals (NASDAQ: PHAT) announced that the FDA has corrected the Orange Book listing for VOQUEZNA® (vonoprazan) tablets, confirming its 10-year New Chemical Entity (NCE) exclusivity period through May 3, 2032. VOQUEZNA, a first-in-class potassium-competitive acid blocker (PCAB), is approved for treating heartburn associated with Non-Erosive GERD and Erosive GERD in adults. The product is also available as VOQUEZNA TRIPLE PAK and DUAL PAK for H. pylori infection treatment. This correction reinforces the long-term commercial potential for this novel GI treatment, ensuring market protection for the full statutory period.

Positive

• Confirmed 10-year regulatory exclusivity period through May 3, 2032, protecting from generic competition
• FDA correction in Orange Book strengthens market protection for VOQUEZNA
• Extended commercial runway for first-in-class GI treatment product

Negative

• Potential future competition after exclusivity period ends
• Success depends on market acceptance and insurance coverage
• Possible unexpected adverse effects could limit commercialization

Insights

Pharmaceutical Patent Analyst

FDA's correction extends VOQUEZNA's market exclusivity to 2032, significantly enhancing Phathom's revenue potential and competitive position.

The FDA's correction to VOQUEZNA's Orange Book listing represents a substantial commercial advantage for Phathom Pharmaceuticals. This administrative update confirms vonoprazan's full 10-year New Chemical Entity exclusivity through May 3, 2032, providing crucial protection against generic competition for their flagship gastrointestinal treatment.

This regulatory clarification potentially adds hundreds of millions in revenue over what might have been a prematurely shortened exclusivity period. For context, NCE exclusivity is one of the strongest forms of regulatory protection in pharmaceuticals, preventing competitors from even filing abbreviated applications for generic versions during this timeframe.

The correction strengthens Phathom's market position across all approved indications for vonoprazan, including non-erosive GERD, erosive GERD, and H. pylori infection treatment. The potassium-competitive acid blocker (PCAB) represents a mechanistically distinct alternative to proton pump inhibitors in the acid suppression market, which exceeds $20 billion globally.

This extended runway allows Phathom to build brand recognition, physician familiarity, and patient adherence without generic erosion concerns. The company can now focus on market penetration rather than lifecycle management strategies typically accelerated when exclusivity windows narrow. The clarification also enhances Phathom's partnership and licensing negotiation leverage for potential international commercialization arrangements.

FLORHAM PARK, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced that the U.S. Food and Drug Administration (FDA) has updated the Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) to accurately reflect the full 10-year period of non-patent New Chemical Entity (NCE) exclusivity for VOQUEZNA® (vonoprazan) 10 mg and 20 mg tablets.

The corrected Orange Book listing confirms that VOQUEZNA is entitled to NCE regulatory exclusivity through May 3, 2032, aligning with statutory requirements and reinforcing the long-term commercial runway for the first-in-class product.

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 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.

FAQ

What is the new exclusivity period for Phathom's VOQUEZNA (PHAT) after FDA's Orange Book correction?

The FDA confirmed VOQUEZNA's 10-year New Chemical Entity exclusivity period through May 3, 2032.

What conditions is VOQUEZNA approved to treat?

VOQUEZNA is approved for treating heartburn associated with Non-Erosive GERD, healing and maintenance of Erosive GERD in adults, and H. pylori infection treatment (as TRIPLE PAK and DUAL PAK).

How does the FDA Orange Book correction impact Phathom Pharmaceuticals (PHAT)?

The correction ensures VOQUEZNA's market protection from generic competition until 2032, strengthening its long-term commercial potential.

What type of drug is VOQUEZNA?

VOQUEZNA (vonoprazan) is a first-in-class potassium-competitive acid blocker (PCAB) for gastrointestinal diseases.

What are the main risks for Phathom's VOQUEZNA commercialization?

Key risks include dependency on insurance coverage, market acceptance by healthcare providers, potential adverse side effects, and future competition after exclusivity ends.