Phathom Pharmaceuticals (PHAT) said Wednesday it has filed a Citizen Petition with the US Food and Drug Administration to request a 10-year New Chemical Entity exclusivity period ending May 3, 2032, for Voquezna (vonoprazan) tablets in the Orange Book listings.
The Orange Book is the common name for the organization's Approved Drug Products with Therapeutic Equivalence Evaluations publication, according to the FDA website.
The company said the exclusivity period, granted under the Generating Antibiotic Incentives Now Act for other vonoprazan-based products approved in 2022, should also apply to VOQUEZNA tablets.
The New Chemical Entity protection prohibits generic competition during the exclusivity period and aligns with legal and regulatory precedents, Phathom said.
The company also said it expects the FDA to respond to the petition within 180 days.
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