ILOPERIDONE | N022192 | VANDA PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Vanda Pharmaceuticals Inc. v. Taro Pharmaceuticals USA, Inc. et al 2 patentsANDA 207098iloperidone | D. Del. | 2015-10-13 | Terminated 2016-10-27 | — |
| D. Del. | 2015-10-13 | Terminated 2022-09-14 | — | |
Vanda Pharmaceuticals Inc. v. Inventia Healthcare Limited 2 patentsANDA 207231iloperidone | D. Del. | 2015-10-13 | Terminated 2025-09-23 | — |
| D. Del. | 2015-10-13 | Terminated 2016-12-09 | — | |
| D. Del. | 2014-06-16 | Terminated 2016-08-25 | — | |
NOVARTIS PHARMACEUTICALS CORPORATION et al v. ROXANE LABORATORIES, INC. 1 patentiloperidone | D.N.J. | 2013-11-27 | Terminated 2015-09-01 | — |
| D. Del. | 2013-11-25 | Terminated 2016-08-25 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Vanda Pharmaceuticals, Inc. FDA-2016-P-2654 · 8 docket documents Vanda Pharmaceuticals Inc. filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner refrain from approving any abbreviated new drug application referencing Fanapt (iloperidone) until May 26, 2019, when three-year exclusivity ex | 505(q) Stay Request | 2016-09-08 | Denied | Vanda Pharmaceuticals, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$60.32
per ea
Lowest NADAC/Unit
$30.50
per ea
Brand NDCs
7
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 43068011002FANAPT 10 MG TABLET | $60.32 | EA | Brand | — | 2026-06-17 |
| 43068011202FANAPT 12 MG TABLET | $60.02 | EA | Brand | — | 2026-06-17 |
| 43068010602FANAPT 6 MG TABLET | $37.69 | EA | Brand | — | 2026-06-17 |
| 43068010802FANAPT 8 MG TABLET | $37.50 | EA | Brand | — | 2026-06-17 |
| 43068010202FANAPT 2 MG TABLET | $30.66 | EA | Brand | — | 2026-06-17 |
| 43068010102FANAPT 1 MG TABLET | $30.61 | EA | Brand | — | 2026-06-17 |
| 43068010402FANAPT 4 MG TABLET | $30.50 | 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 |
|---|---|---|---|---|---|---|
| 8586610 | Nov 2, 2027 | — | — | — | — | |
| 8652776 | Aug 31, 2030 | — | — | — | — | |
| 8999638 | Oct 28, 2030 | — | — | — | — | |
| 9072742 | Jan 16, 2031 | — | — | — | — | |
| 9074254 | Dec 28, 2031 | — | — | — | — | |
| 9074255 | Dec 17, 2030 | — | — | — | — | |
| 9074256 | Feb 10, 2031 | — | — | — | — | |
| 9157121 | Apr 5, 2030 | — | — | — | — | |
| 10563259Newly listed — daily FDA feed, not yet in monthly Orange Book edition | Jul 24, 2030 | — | — | — | — | |
| 10570453Newly listed — daily FDA feed, not yet in monthly Orange Book edition | Mar 28, 2028 | — | — | — | — | |
| 12606869 | Sep 22, 2030 | — | — | — | — |
| Code | Date | Status |
|---|---|---|
| I-939 | Apr 2, 2027 | < 1 year |