Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.
VONOPRAZAN FUMARATE | N218710 | PHATHOM PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Phathom Pharmaceuticals, Inc. FDA-2024-P-5703 · 7 docket documents Phathom Pharmaceuticals, Inc. filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA correct the Orange Book to accurately reflect a full ten-year period of new chemical entity exclusivity for VOQUEZNA (vonoprazan tablets, approved under NDA | 505(q) | 2024-12-11 | Granted | Phathom Pharmaceuticals, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.