Phathom Pharmaceuticals Inc. has announced a significant update from the U.S. Food and Drug Administration (FDA) regarding its gastrointestinal treatment, VOQUEZNA® (vonoprazan) tablets. The FDA has corrected its Orange Book listing to accurately reflect a full 10-year period of non-patent New Chemical Entity (NCE) exclusivity for VOQUEZNA, effective through May 3, 2032. This update affirms the long-term commercial potential of the product as a first-in-class treatment. The exclusivity ensures that VOQUEZNA remains protected from generic competition in the U.S., solidifying its market position. No other organizations are involved in this regulatory exclusivity update.
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