Tuesday, 4 Nov 2025
  • About Us
  • Contact Us
  • Terms and Conditions
  • Privacy Policy
Subscribe
Life Care News
  • Home
  • Business
    • Business Wire
    • Globenews Wire
  • News
    NewsShow More
    Manulife Completes Acquisition of Comvest Credit Partners
    Manulife Completes Acquisition of Comvest Credit Partners
    03/11/2025
    Inaugural Abu Dhabi Autonomous Summit reveals programme, spotlighting regulation, real-world deployments and cross-sector scale
    Inaugural Abu Dhabi Autonomous Summit reveals programme, spotlighting regulation, real-world deployments and cross-sector scale
    03/11/2025
    Over 600 Customers Visit Liberty General Insurance Branches During Customer Experience Week 2025, Celebrating Trust and Service Excellence
    Over 600 Customers Visit Liberty General Insurance Branches During Customer Experience Week 2025, Celebrating Trust and Service Excellence
    02/11/2025
    Enfinity Global to Supply 400 GWh Guarantees of Origin to VW Kraftwerk GmbH to Support Sustainable Mobility
    Enfinity Global to Supply 400 GWh Guarantees of Origin to VW Kraftwerk GmbH to Support Sustainable Mobility
    02/11/2025
    Isolation to Inclusion: Znabou’s Story
    Isolation to Inclusion: Znabou’s Story
    02/11/2025
  • Tech
  • Health
  • Sports
  • Entertainment
  • Automobile
  • 🔥
  • news
  • global
  • Business
  •  and
  • announced
  • today
  •  the
  • june
  • company
  • Tech
Font ResizerAa
Life Care NewsLife Care News
  • Home
  • Business
  • News
  • Tech
  • Health
  • Sports
  • Entertainment
  • Automobile
Search
  • Home
  • Business
    • Business Wire
    • Globenews Wire
  • News
  • Tech
  • Health
  • Sports
  • Entertainment
  • Automobile
Follow US
© 2022 Foxiz News Network. Ruby Design Company. All Rights Reserved.
Health

Phathom Pharmaceuticals Announces Positive FDA Decision to Recognize 10 Years of Regulatory Exclusivity for VOQUEZNA (vonoprazan) Tablets through May 3, 2032

GlobeNews Wire
Last updated: 09/06/2025 3:53 AM
GlobeNews Wire
Share
4 Min Read
Phathom Pharmaceuticals Announces Positive FDA Decision to Recognize 10 Years of Regulatory Exclusivity for VOQUEZNA (vonoprazan) Tablets through May 3, 2032
SHARE
Phathom Pharmaceuticals Announces Positive FDA Decision to Recognize 10 Years of Regulatory Exclusivity for VOQUEZNA (vonoprazan) Tablets through May 3, 2032

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.

Monolithic Power Systems Announces Second Quarter 2025 Dividend
Aramco signs $11 billion Jafurah midstream deal with international consortium led by Global Infrastructure Partners
Government Push for Generic Drugs Finds Digital Ally in New Healthcare Portal
Hikal introduces Digital Infrastructure at 130 year old Zilla Parishad School in Alibaug
Press Release Biocartis NV: Biocartis Announces IVDR Class C CDx Certification of the Idylla EGFR Mutation Test
TAGGED:adultsanyassociatedbookcommercializationcompanysdevelopmentexclusivityforwardlookingheartburnincludingmaynonpatentobtainorangepatentpharmaceuticalsphathomphathomspressprotectionregulatoryreliefstatementsstatestabletsunitedvonoprazanvoquezna
Share This Article
Facebook Copy Link Print
- Advertisement -

Your Trusted Source for Accurate and Timely Updates!

Our commitment to accuracy, impartiality, and delivering breaking news as it happens has earned us the trust of a vast audience. Stay ahead with real-time updates on the latest events, trends.
FacebookLike
XFollow
PinterestPin
InstagramFollow
YoutubeSubscribe
LinkedInFollow
MediumFollow

Most Selling Products

Top Picks, Trending Now – Discover the Best Sellers!
Tecno Camon 20 Premier 5G

Tecno Camon 20 Premier 5G

Dark Welkin | 8GB RAM + 512GB Storage (Expandable RAM up to 16GB) | Industry’s 1st 50MP RGBW-Pro Camera | Segment-First 108MP Ultra-Wide Macro Lens | 6.67" 120Hz 10-bit AMOLED In-Display

iQOO Z10 Lite 5G

iQOO Z10 Lite 5G

Titanium Blue | 6GB RAM + 128GB Storage | Dimensity 6300 5G with 433K+ AnTuTu Score | Robust 6000mAh Battery | IP64 Rated + Military-Grade Shock Resistance

OnePlus 13s

OnePlus 13s

Black Velvet | 12GB RAM + 256GB Storage | Flagship Snapdragon® 8 Elite Chipset | Exceptional Battery Life in a Compact Form | Lifetime Display Warranty Included

Samsung Galaxy A55 5G

Samsung Galaxy A55 5G

Awesome Iceblue | 8GB RAM + 256GB Storage | Premium Metal Frame | 50MP OIS Main Camera with Nightography | IP67 Water & Dust Resistance | Gorilla Glass Victus+ | sAMOLED Display with Vision Booster

You Might Also Like

Manulife Completes Acquisition of Comvest Credit Partners
Tech

Rockefeller Foundation Announces First Class of Big Bets Fellows Focused on Asia-Pacific

11/06/2025
XORTX Completes USD 4,500 Private Placement
Health

XORTX Completes USD $114,500 Private Placement

10/08/2025
Singapore Unveils Insights from World’s First Technical Testing of Real World Applications of GenAI
Entertainment

Singapore Unveils Insights from World’s First Technical Testing of Real World Applications of GenAI

31/05/2025
Anteris Technologies Announces First Patients Treated in DurAVR THV Global Pivotal Trial (the PARADIGM Trial)
Health

Anteris Technologies Announces First Patients Treated in DurAVR THV Global Pivotal Trial (the PARADIGM Trial)

28/10/2025
Life Care News
Facebook Twitter Youtube Rss Medium

Life Care News:


We increase the awareness of millions of users through our news networks. We are one of the most trusted news networks in the world.

Top Categories
  • Home
  • Business
  • News
  • Tech
  • Health
  • Sports
  • Entertainment
  • Automobile
Usefull Links
  • About Us
  • Contact Us
  • Terms and Conditions
  • Privacy Policy
Copyright © 2015 – 2025 LifeCareNews Network. All Rights Reserved. LIFE CARE IS REGISTERED MAGAZINE IN RNI, NO.GUJGUJ/2015/71283
Life Care NewsLife Care News
Copyright © 2015 - 2025 LifeCareNews Network. All Rights Reserved. LIFE CARE IS REGISTERED MAGAZINE IN RNI, NO.GUJGUJ/2015/71283
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?