Phathom Positive FDA Decision to Recognize 10 Years of Regulatory Exclusivity for VOQUEZNA

 

• The FDA grants Phathom Pharmaceuticals (PHAT, Financial) 10 years of regulatory exclusivity for VOQUEZNA, extending through May 3, 2032.
• This decision protects VOQUEZNA from generic competition, enhancing Phathom's market position and revenue potential.
• VOQUEZNA treats Non-Erosive GERD, Erosive GERD, and H. pylori infection.

Phathom Pharmaceuticals, Inc. (PHAT) announced a significant victory as the U.S. Food and Drug Administration (FDA) approved their Citizen Petition, affirming 10 years of New Chemical Entity exclusivity for VOQUEZNA® (vonoprazan) tablets until May 3, 2032. This exclusivity prevents generic manufacturers from entering the market with a similar product until the specified period ends.

VOQUEZNA is a first-in-class potassium-competitive acid blocker (PCAB) and is currently marketed in the United States for the treatment of heartburn associated with Non-Erosive GERD in adults, as well as the healing and maintenance of Erosive GERD. In addition, it is available as VOQUEZNA TRIPLE PAK and DUAL PAK for the treatment of H. pylori infections in adults.

The FDA's decision to correct the Orange Book and grant the full exclusivity period enhances Phathom's competitive edge, securing their intellectual property rights for an extended duration and providing a robust commercial runway. 

https://www.gurufocus.com/news/2913427/phathom-pharmaceuticals-announces-positive-fda-decision-to-recognize-10-years-of-regulatory-exclusivity-for-voquezna-vonoprazan-tablets-through-may-3-2032-phat-stock-news