VARENICLINE TARTRATE | N021928 | PF PRISM CV
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2021-09-30 | Terminated 2021-10-19 | — | |
| D. Del. | 2020-01-31 | Terminated 2020-09-18 | — | |
| S.D.N.Y. | 2019-01-22 | Terminated 2019-03-15 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Medley Pharmaceuticals Ltd. FDA-2022-P-1013 · 6 docket documents Medley Pharmaceuticals Ltd. filed this citizen petition pursuant to FDC Act Section 505(j) and 21 CFR Section 314.122 and 314.161 requesting that the FDA determine whether Chantix (Varenicline Tartrate) Tablets 0.5 mg and 1 mg, approved under NDA 021928 and held by PF PRISM CV, was not withdrawn for | 505(q) | 2022-06-06 | Granted | Medley Pharmaceuticals Ltd. |
Citizen Petition from the Institute for Safe Medication Practices FDA-2014-P-1562 · 4 docket documents Five nonprofit organizations—the Institute for Safe Medication Practices, Consumer Reports, National Center for Health Research, National Physicians Alliance, and Public Citizen—filed this citizen petition in October 2014 pursuant to 21 USC 352, 505(o)(4), and 21 CFR 10.30 requesting that the FDA am | Other | 2014-11-06 | Partially Denied | the Institute for Safe Medication Practices |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$3.41
per ea
Lowest NADAC/Unit
$3.40
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00069046928CHANTIX 1 MG CONT MONTH BOX | $3.41 | EA | Brand | $0.4185 | 2026-06-17 |
| 00069046956CHANTIX 1 MG TABLET | $3.41 | EA | Brand | $0.4185 | 2026-06-17 |
| 00069047128CHANTIX STARTING MONTH BOX | $3.40 | EA | Brand | $0.4919 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.