POSACONAZOLE | N205596 | MERCK SHARP AND DOHME CORP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2022-09-08 | Terminated 2023-06-26 | — | |
MERCK SHARP & DOHME CORP. v. AUROBINDO PHARMA USA INC. et al 2 patentsANDA 214842posaconazole | D.N.J. | 2020-08-13 | Terminated 2020-12-22 | — |
MERCK SHARP & DOHME CORP. v. MYLAN LABORATORIES LIMITED 2 patentsANDA 211500posaconazole | E.D. Pa. | 2018-03-29 | Terminated 2018-05-21 | — |
| D. Del. | 2018-03-23 | Terminated 2019-07-15 | — | |
Merck Sharp & Dohme Corp. v. Mylan Laboratories Limited 2 patentsANDA 209983posaconazole | D. Del. | 2018-02-02 | Terminated 2019-07-15 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Withdrawal of Suitability Petition from Reyoung Pharmaceutical Co., Ltd. FDA-2022-P-1833 · 5 docket documents 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 | Suitability | 2023-11-21 | Withdrawn | Reyoung Pharmaceutical Co., Ltd.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 · 5 docket documents 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 | Suitability | 2023-03-31 | Withdrawn | Reyoung Pharmaceutical Co., Ltd. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| NPP | Jan 27, 2029 | Active |
| ODE-355 | Jun 17, 2028 | Active |