{"id":860759,"date":"2025-06-16T08:17:16","date_gmt":"2025-06-16T12:17:16","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032\/"},"modified":"2025-06-16T08:17:16","modified_gmt":"2025-06-16T12:17:16","slug":"phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032\/","title":{"rendered":"Phathom Pharmaceuticals Announces FDA Correction to Orange Book Listing, Confirming 10 Years of Regulatory Exclusivity for VOQUEZNA\u00ae (vonoprazan) Tablets Through May 3, 2032"},"content":{"rendered":"<div class=\"mw_release\">\n<p>FLORHAM PARK, N.J., June  16, 2025  (GLOBE NEWSWIRE) &#8212; 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 <em>Approved Drug Products with Therapeutic Equivalence Evaluations<\/em> (the \u201cOrange Book\u201d) to accurately reflect the full 10-year period of non-patent New Chemical Entity (NCE) exclusivity for VOQUEZNA\u00ae (vonoprazan) 10 mg and 20 mg tablets.<\/p>\n<p>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.<\/p>\n<p>\n        <strong><br \/>\n          <u>About Phathom Pharmaceuticals, Inc.<\/u><br \/>\n        <\/strong><br \/>\n        <br \/>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\u00ae (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\u00ae TRIPLE PAK\u00ae (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA\u00ae DUAL PAK\u00ae (vonoprazan tablets, amoxicillin capsules) for the treatment of <em>H. pylori<\/em> infection in adults. For more information about Phathom, visit the company\u2019s website at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=-AX8X_9dmcM-KW8zjdEIoQsduurI0gy3lP1hqgI3shgUpWPlTur5qyH69IvCOEOF8wzefOuPJFvCHej1kGLhOXqX2_GOdBfWLj3PJxaosPM=\" rel=\"nofollow\" target=\"_blank\">www.phathompharma.com<\/a> and follow on <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=SpZSjf2LUNJyfZHlKcXmB_dTkK8FBnDBX-2aWX2gXuPqoJAt0QYdZOTp6U7qYKQTB5iDic5CVdi-YxH66jstm4HSbONTv-xklIJjwWEDOSA=\" rel=\"nofollow\" target=\"_blank\">LinkedIn<\/a>\u00a0and\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=mrETMvIy9D0qYuOMnvH308JbiscYmxos39HVlcAaLaFqFdNjkm0PKfd_ANmJkwb3SjwtV1zQXc6BKEpstXAetA==\" rel=\"nofollow\" target=\"_blank\">X<\/a>.<\/p>\n<p>\n        <strong><br \/>\n          <u>Forward-Looking Statements<\/u><br \/>\n        <\/strong><br \/>\n        <br \/>This press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about Phathom\u2019s 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\u2019s 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\u2019s 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\u2019s ability to obtain and maintain intellectual property protection and non-patent regulatory exclusivity for vonoprazan; and other risks described in the Company\u2019s prior press releases and the Company\u2019s filings with the Securities and Exchange Commission (SEC), including under the heading \u201cRisk Factors\u201d in the Company\u2019s 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.<\/p>\n<p>\n        <strong>MEDIA CONTACT<\/strong><br \/>\n        <br \/>Nick Benedetto<br \/>1-877-742-8466<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=GzAyr_8ZcldXihkoeO6goOiefBirP_8-lrefAwQFPrfNWK63rceacXQ64hITFkmzC-D5hqwhRtOhMGx4-AC72u9zHevixeGrMr3AwbWgb_M=\" rel=\"nofollow\" target=\"_blank\">media@phathompharma.com<\/a><\/p>\n<p>\n        <strong>INVESTOR CONTACT<\/strong><br \/>\n        <br \/>Eric Sciorilli<br \/>1-877-742-8466<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=5dYWc4NigFTk81Cpj_kOLjQj11yQDFoO64kzFcUG58drPvF2UV6AnG1eYqDluY07SkiKivqZPcyeSHurixbxHIOdVCfxmv8pvDo1HXz69ms=\" rel=\"nofollow\" target=\"_blank\">ir@phathompharma.com<\/a><\/p>\n<p>\u00a9 2025 Phathom Pharmaceuticals. All rights reserved.<br \/>VOQUEZNA, VOQUEZNA DUAL PAK, VOQUEZNA TRIPLE PAK, Phathom Pharmaceuticals, and their respective logos are registered trademarks of Phathom Pharmaceuticals, Inc.<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ2OTAxMiM2OTkxNjUxIzIxODk1NzI=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/Yzk3MDYyYjQtNTViZC00YTM2LWJkZmYtOTk0OTAwOTdiNzJkLTEyMDExMjUtMjAyNS0wNi0xNi1lbg==\/tiny\/Phathom-Pharmaceuticals.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>FLORHAM PARK, N.J., June 16, 2025 (GLOBE NEWSWIRE) &#8212; 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 \u201cOrange Book\u201d) to accurately reflect the full 10-year period of non-patent New Chemical Entity (NCE) exclusivity for VOQUEZNA\u00ae (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 &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Phathom Pharmaceuticals Announces FDA Correction to Orange Book Listing, Confirming 10 Years of Regulatory Exclusivity for VOQUEZNA\u00ae (vonoprazan) Tablets Through May 3, 2032&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-860759","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Phathom Pharmaceuticals Announces FDA Correction to Orange Book Listing, Confirming 10 Years of Regulatory Exclusivity for VOQUEZNA\u00ae (vonoprazan) Tablets Through May 3, 2032 - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Phathom Pharmaceuticals Announces FDA Correction to Orange Book Listing, Confirming 10 Years of Regulatory Exclusivity for VOQUEZNA\u00ae (vonoprazan) Tablets Through May 3, 2032 - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"FLORHAM PARK, N.J., June 16, 2025 (GLOBE NEWSWIRE) &#8212; 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 \u201cOrange Book\u201d) to accurately reflect the full 10-year period of non-patent New Chemical Entity (NCE) exclusivity for VOQUEZNA\u00ae (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 &hellip; Continue reading &quot;Phathom Pharmaceuticals Announces FDA Correction to Orange Book Listing, Confirming 10 Years of Regulatory Exclusivity for VOQUEZNA\u00ae (vonoprazan) Tablets Through May 3, 2032&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-06-16T12:17:16+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ2OTAxMiM2OTkxNjUxIzIxODk1NzI=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Phathom Pharmaceuticals Announces FDA Correction to Orange Book Listing, Confirming 10 Years of Regulatory Exclusivity for VOQUEZNA\u00ae (vonoprazan) Tablets Through May 3, 2032\",\"datePublished\":\"2025-06-16T12:17:16+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032\\\/\"},\"wordCount\":634,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTQ2OTAxMiM2OTkxNjUxIzIxODk1NzI=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032\\\/\",\"name\":\"Phathom Pharmaceuticals Announces FDA Correction to Orange Book Listing, Confirming 10 Years of Regulatory Exclusivity for VOQUEZNA\u00ae (vonoprazan) Tablets Through May 3, 2032 - 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(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 \u201cOrange Book\u201d) to accurately reflect the full 10-year period of non-patent New Chemical Entity (NCE) exclusivity for VOQUEZNA\u00ae (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 &hellip; Continue reading \"Phathom Pharmaceuticals Announces FDA Correction to Orange Book Listing, Confirming 10 Years of Regulatory Exclusivity for VOQUEZNA\u00ae (vonoprazan) Tablets Through May 3, 2032\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032\/","og_site_name":"Market Newsdesk","article_published_time":"2025-06-16T12:17:16+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ2OTAxMiM2OTkxNjUxIzIxODk1NzI=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Phathom Pharmaceuticals Announces FDA Correction to Orange Book Listing, Confirming 10 Years of Regulatory Exclusivity for VOQUEZNA\u00ae (vonoprazan) Tablets Through May 3, 2032","datePublished":"2025-06-16T12:17:16+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032\/"},"wordCount":634,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ2OTAxMiM2OTkxNjUxIzIxODk1NzI=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/phathom-pharmaceuticals-announces-fda-correction-to-orange-book-listing-confirming-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032\/","name":"Phathom Pharmaceuticals Announces FDA Correction to Orange Book Listing, Confirming 10 Years of Regulatory Exclusivity for VOQUEZNA\u00ae (vonoprazan) Tablets Through May 3, 2032 - 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