Phathom Pharmaceuticals Submits Citizen Petition To FDA Seeking Correction Of Orange Book Listings For VOQUEZNA Tablets; Phathom Believes Applicable Law Mandates A 10-Year NCE Exclusivity Period Benefitting All Vonoprazan-Based Products, With Excl...

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Citizen Petition seeks correction of expiration date for New Chemical Entity (NCE) exclusivity on VOQUEZNA (vonoprazan) tablets Orange Book listings
Phathom believes applicable law mandates a 10-year NCE exclusivity period (from date of first approval of drug containing vonoprazan) benefitting all vonoprazan-based products, with exclusivity until May 3, 2032

FLORHAM PARK, N.J., Dec. 11, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced today it has submitted a Citizen Petition (CP) with the U.S. Food and Drug Administration (FDA). The petition formally requests correction of the Orange Book listings for VOQUEZNA (vonoprazan) 10 mg and 20 mg tablets to accurately reflect the full 10-year NCE exclusivity period until May 3, 2032.

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