Phathom Pharmaceuticals, Inc. a biopharmaceutical company focused on advancing novel treatments for gastrointestinal (GI) diseases, has taken a decisive step to protect its innovative drug, VOQUEZNA (vonoprazan), by submitting a Citizen Petition (CP) to the U.S. Food and Drug Administration (FDA). Announced on December 11, 2024, the petition requests a revision in the Orange Book listings for its 10 mg and 20 mg tablet formulations of VOQUEZNA to ensure the full 10-year New Chemical Entity (NCE) exclusivity is applied, projecting extended exclusivity until May 3, 2032.
The Citizen Petition represents Phathom Pharmaceuticals efforts to safeguard its intellectual property rights concerning VOQUEZNA, a drug indicated for treating erosive esophagitis, also known as erosive gastroesophageal reflux disease (GERD), and relieving heartburn associated with this condition. This drug is particularly significant as it is the first potassium-competitive acid blocker (PCAB) approved by the FDA for erosive GERD, marking a novel class of acid blocker making waves in the therapeutic landscape after more than three decades in the United States.
Earlier in the year, Phathom Pharmaceuticals announced another critical milestone for VOQUEZNA. As of February 13, 2024, the medication has been successfully added to Express Scripts national formularies for commercial patients. This development implies expanded access for VOQUEZNA, benefiting an estimated 60 million covered lives across the United States. The placement on these formularies essentially facilitates greater commercial availability and exemplifies a crucial achievement in ensuring that more patients can obtain this innovative treatment for erosive GERD.
Positioning VOQUEZNA in this influential spot on Express Scripts’ formularies underscores the drug’s recognized value and potential impact in treating a condition calling for more advanced therapeutic options. By being accessible through significant retail pharmacies and platforms like BlinkRx, VOQUEZNA s commercial reach has broadened, underscoring the pharmaceutical company’s dedication to delivering breakthrough GI treatments to a wider audience.
Phathom Pharmaceuticals consistent efforts, culminating in these recent developments, demonstrate the company’s to lead in the GI treatment field. As the discussions with the FDA progress, the outcome of the Citizen Petition will potentially shape the market landscape for treatments related to erosive GERD, further influencing both patients and industry players alike.
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