Sign in Subscribe
Stock exchanges

Phathom Pharmaceuticals Updates Orange Book Listing for VOQUEZNA, Securing 10-Year Regulatory Exclusivity

Strategic Insights

— 2 min read

Phathom Pharmaceuticals has filed a Form 8-K report with the U.S. Securities and Exchange Commission (SEC) on July 16, 2025, announcing 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. This correction 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.

Key Takeaways:

  • Phathom Pharmaceuticals has filed a Form 8-K report with the U.S. Securities and Exchange Commission (SEC) on July 16, 2025, announcing an update to the Orange Book listing for VOQUEZNA (vonoprazan).
  • The FDA has updated the Orange Book to accurately reflect the full 10-year period of non-patent New Chemical Entity (NCE) exclusivity for VOQUEZNA 10 mg and 20 mg tablets, effective through May 3, 2032.
  • This correction confirms that VOQUEZNA is entitled to NCE regulatory exclusivity, aligning with statutory requirements and reinforcing the long-term commercial runway for the first-in-class product.
  • The update affects Phathom's commercialization plans for VOQUEZNA, VOQUEZNA TRIPLE PAK, and VOQUEZNA DUAL PAK, which will depend on coverage and reimbursement levels from governmental authorities and health insurers, as well as market acceptance by healthcare providers.
  • The Company may face competition in the future if it loses or fails to obtain its patent protection or non-patent regulatory exclusivity for VOQUEZNA tablets.
  • The update is subject to various risks and uncertainties, including regulatory developments in the United States and foreign countries, unexpected adverse side effects or inadequate efficacy of vonoprazan, and others described in the Company's filings with the SEC.

Statistics:

  • VOQUEZNA is entitled to NCE regulatory exclusivity through May 3, 2032.
  • The NCE exclusivity period is a 10-year period of non-patent protection granted by the FDA for new chemical entities.
  • VOQUEZNA is the first-in-class product for vonoprazan.
  • The correction is effective as of the date of the Orange Book update.
  • The update affects Phathom's commercialization plans for VOQUEZNA, VOQUEZNA TRIPLE PAK, and VOQUEZNA DUAL PAK.

Sources:

  • UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
  • PHATHOM PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-39094 82-4151574 (State or other jurisdiction of incorporation or organization) (Commission File Number) (I.R.S. Employer Identification No.) 100 Campus Drive, Suite 102 Florham Park, New Jersey 07932 (Address of principal executive offices) (Zip Code) (877) 742-8466 (Registrant's telephone number, include area code)
  • Phathom Pharmaceuticals' Form 10-K Annual Report filed with the SEC for the fiscal year ended December 31, 2024.

Read more