UBROGEPANT | N211765 | ABBVIE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pharmobedient Consulting, LLC FDA-2025-P-3512 Pharmobedient Consulting, LLC filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Ubrogepant Orally Disintegrating Tablets in 50 mg and 100 mg strengths suitable for submission in an ANDA, with the reference listed drug | Suitability | 2025-09-04 | Open | Pharmobedient Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8754096 | Jul 19, 2032 | — | Yes | Yes | — | |
| 8912210 | Dec 23, 2033 | — | Yes | Yes | — | — |
| 9499545 | Nov 10, 2031 | — | Yes | Yes | — | |
| 9833448 | Nov 10, 2031 | — | — | — | — | |
| 10117836 | Jan 30, 2035 | — | — | Yes | — | — |
| 11717515 | Dec 22, 2041 | — | — | — | — | |
| 11857542 | Dec 22, 2041 | — | — | — | — | |
| 11925709 | Jan 30, 2035 | — | — | Yes | — | — |
| 12168004 | Jan 30, 2035 | — | — | Yes | — | — |
| 12194030 | Dec 22, 2041 | — | — | — | — | |
| 12220408 | Jan 30, 2035 | — | — | Yes | — | — |
| 12310953 | Jan 30, 2035 | — | — | Yes | — | — |
| 12329750 | Dec 22, 2041 | — | — | — | — | |
| 12458632 | Jan 30, 2035 | — | — | Yes | — | — |
| 12458633 | Jan 30, 2035 | — | — | Yes | — | — |