FDA grants Phathom citizen petition; VOQUEZNA exclusivity extended to May 2032

Phathom Pharmaceuticals, Inc.

FDA approved Phathom's 2024 citizen petition to correct Orange Book for VOQUEZNA (vonoprazan) tablets.
VOQUEZNA will benefit from the 10-year NCE*GAIN exclusivity originally awarded to VOQUEZNA Triple Pak and Dual Pak.
FDA will update Orange Book to reflect exclusivity extending through May 3, 2032 (previously May 3, 2027).
Decision protects VOQUEZNA from generic competition for an additional 5 years under FDA's umbrella policy.
VOQUEZNA was not itself designated as a QIDP, but the exclusivity attaches to the active moiety vonoprazan.

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