POSACONAZOLE | N205053 | MERCK SHARP AND DOHME CORP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC. et al 1 patentANDA 207355Posaconazole | D.N.J. | 2015-08-06 | Terminated 2017-09-29 | — |
| D. Del. | 2015-05-29 | Terminated 2019-07-26 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Aizant Drug Research Solutions Private Limited FDA-2024-P-4163 Aizant Drug Research Solutions Private Limited submitted this citizen petition under 21 CFR 10.25, 10.30, 314.122, and 314.161 requesting that the FDA determine whether the reference listed drug NOXAFIL (posaconazole) delayed-release tablets 1.2 g (NDA N205053), held by Merck Sharp and Dohme Corp, w | 505(q) | 2024-09-03 | Granted | Aizant Drug Research Solutions Private Limited |
Withdrawal of Suitability Petition from Reyoung Pharmaceutical Co., Ltd. FDA-2023-P-1227 Reyoung Pharmaceutical Co., Ltd. submitted this letter on November 21, 2023 to withdraw its suitability petition (FDA docket number FDA-2023-P-1227) requesting that the FDA declare posaconazole for delayed-release oral suspension, USP, 300 mg suitable for consideration in an Abbreviated New Drug App | Suitability | 2023-11-21 | Withdrawn | Reyoung Pharmaceutical Co., Ltd. |
Withdrawal of Suitability Petition from Reyoung Pharmaceutical Co., Ltd. FDA-2022-P-1833 Reyoung Pharmaceutical Co., Ltd. filed this letter on November 21, 2023, to withdraw its suitability petition (FDA-2022-P-1833) requesting FDA declaration that posaconazole delayed-release oral suspension, USP, 100 mg, is suitable for consideration in an Abbreviated New Drug Application. | Suitability | 2023-11-21 | Withdrawn | Reyoung Pharmaceutical Co., Ltd. |
Attachment 2 - Draft Package Insert Proposed for posaconazole for delayed-rel... FDA-2023-P-1227 Reyoung Pharmaceutical Co., Ltd. filed a Suitability Petition regarding posaconazole for delayed-release oral suspension, USP, 100 mg, and submitted a draft package insert for the product as part of the petition. | Suitability | 2023-03-31 | Withdrawn | Reyoung Pharmaceutical Co., Ltd. |
Attachment 1 - Current labeling for NOXAFIL® (posaconazole) delayed-release t... FDA-2023-P-1227 Reyoung Pharmaceutical Co., Ltd. filed a suitability petition regarding posaconazole delayed-release tablets 100 mg (NOXAFIL), an NDA product held by Merck Sharp and Dohme Corp under NDA 205053, though the specific requested action is not detailed in the provided text. | Suitability | 2023-03-31 | Withdrawn | Reyoung Pharmaceutical Co., Ltd. |
Suitability Petition from Reyoung Pharmaceutical Co Ltd FDA-2022-P-1833 Reyoung Pharmaceutical Co., Ltd. filed this suitability petition under Section 505(j)(2)(C) of the FD&C Act requesting FDA approval to submit an ANDA for posaconazole delayed-release oral suspension, 100 mg, which differs from the reference listed drug NOXAFIL delayed-release tablets, 100 mg (NDA 20 | Suitability | 2022-08-09 | Withdrawn | Reyoung Pharmaceutical Co Ltd |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$2.07
per ea
Lowest NADAC/Unit
$2.07
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00254204502POSACONAZOLE DR 100 MG TABLET | $2.07 | EA | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Code | Date | Status |
|---|---|---|
| NPP | Jan 27, 2029 | Active |
| ODE-355 | Jun 17, 2028 | Active |