UBROGEPANT | N211765 | ABBVIE INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2024-04-11 | Active | — | |
| D.N.J. | 2024-04-08 | Terminated 2025-12-03 | — | |
ABBVIE INC. et al v. ZYDUS PHARMACEUTICALS (USA) INC. et al 8 patentsANDA 218662ubrogepant | D.N.J. | 2024-04-05 | Active | — |
| D.N.J. | 2024-03-29 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pharmobedient Consulting, LLC FDA-2025-P-3512 · 8 docket documents 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 | Denied | Pharmobedient Consulting, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$109.18
per ea
Lowest NADAC/Unit
$108.97
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00023650110UBRELVY 100 MG TABLET | $109.18 | EA | Brand | — | 2026-06-17 |
| 00023650116UBRELVY 100 MG TABLET | $109.18 | EA | Brand | — | 2026-06-17 |
| 00023649810UBRELVY 50 MG TABLET | $108.97 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| 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 | — | — |