regulatory
confidence high
sentiment positive
materiality 0.65
FDA Orange Book corrected; VOQUEZNA NCE exclusivity confirmed through May 2032
Phathom Pharmaceuticals, Inc.
- FDA updated Orange Book to show full 10-year NCE exclusivity for VOQUEZNA (vonoprazan) 10 mg and 20 mg tablets.
- Corrected listing confirms exclusivity runs through May 3, 2032, aligning with statutory requirements.
- Phathom says this reinforces the long-term commercial runway for its first-in-class product.
- NCE exclusivity prevents generic competition for the full 10-year period from approval date.
item 8.01