Phathom Pharmaceuticals announced that the FDA established a public docket to solicit comments on regulatory questions regarding BDR Pharmaceuticals' challenge to VOQUEZNA's 10-year New Chemical Entity (NCE) exclusivity, which is set to expire May 3, 2032. Phathom plans to intervene in the litigation and submit comments to defend its statutory exclusivities. A second ANDA filer, Saba Ilac, has also indicated intent to consolidate its case with BDR's.
PHAT
Phathom Pharmaceuticals, Inc.About PHAT
Phathom Pharmaceuticals Inc operates as a clinical-stage biopharmaceutical company. The firm is focused on developing and commercializing novel treatments for gastrointestinal, or GI, diseases. Its product comprises vonoprazan, an oral small-molecule potassium competitive acid blocker medicine that blocks acid secretion in the stomach. Vonoprazan shows rapid, potent, and durable anti-secretory effects and has demonstrated clinical benefits in the treatment of gastroesophageal reflux disease, and in combination with antibiotics for the treatment of Helicobacter pylori infection.
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BDR Pharmaceuticals filed suit against the FDA challenging the agency's application of the GAIN Act to extend Phathom Pharmaceuticals' New Chemical Entity (NCE) exclusivity for VOQUEZNA (vonoprazan) through May 2032. Phathom believes the FDA correctly evaluated the issue and intends to defend its statutory exclusivities.
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