Phathom Pharma: FDA Updates Orange Book To Reflect 10 Year NCE Regulatory Exclusivity For VOQUEZNA

(RTTNews) - Phathom Pharmaceuticals, Inc. (PHAT) announced Monday that the U.S. Food and Drug Administration has updated the Approved Drug Products with Therapeutic Equivalence Evaluations, i.e., the Orange Book. The update accurately reflects the full 10-year period of non-patent New Chemical Entity or NCE exclusivity for VOQUEZNA (vonoprazan) 10 mg and 20 mg tablets.

The biopharmaceutical company focused on gastrointestinal diseases noted that the corrected Orange Book listing confirms that VOQUEZNA is entitled to NCE regulatory exclusivity through May 3, 2032.

This aligns with statutory requirements and reinforcing the long-term commercial runway for the first-in-class product.

Phathom has in-licensed the exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB). It is currently marketed in the U.S. as VOQUEZNA (vonoprazan) tablets for the relief of heartburn associated with Non-Erosive GERD in adults, among others.

In the pre-market activity on the Nasdaq, Phathom shares were gaining around 1.5 percent to trade at $10.80.