VASOPRESSIN | N204485 | PH HEALTH LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2025-12-18 | Active | — | |
Endo USA, Inc. and Endo Operations Limited v. Baxter Healthcare Corporation 3 patentsvasopressin | D. Del. | 2023-03-29 | Terminated 2025-02-13 | — |
| D.N.J. | 2023-02-28 | Terminated 2023-04-27 | — | |
| D.N.J. | 2022-05-13 | Terminated 2023-09-26 | — | |
PAR PHARMACEUTICAL, INC. et al v. DR. REDDY'S LABORATORIES, INC et al 1 patentANDA 213988Vasopressin | D.N.J. | 2020-12-07 | Terminated 2021-02-01 | — |
PAR PHARMACEUTICAL, INC. et al v. EAGLE PHARMACEUTICALS, INC. 1 patentANDA 211538vasopressin | D.N.J. | 2020-12-07 | Terminated 2022-05-10 | — |
PAR PHARMACEUTICAL, INC. et al v. AMNEAL EU, LIMITED et al 1 patentANDA 212944, 212945vasopressin | D.N.J. | 2020-12-07 | Terminated 2022-02-10 | — |
PAR PHARMACEUTICAL, INC. et al v. AUROBINDO PHARMA U.S.A., INC. et al 1 patentANDA 214314vasopressin | D.N.J. | 2020-12-07 | Terminated 2021-01-28 | — |
Par Pharmaceutical, Inc. et al v. Fresenius Kabi USA, LLC 5 patentsANDA 213205, 213206vasopressin | D. Del. | 2019-10-18 | Terminated 2020-10-01 | — |
| D. Del. | 2019-08-09 | Terminated 2020-05-21 | — | |
Par Pharmaceutical, Inc. et al v. Amneal Pharmaceuticals Company GmbH et al 2 patentsANDA 212944, 212945vasopressin | D. Del. | 2019-04-18 | Terminated 2022-02-09 | — |
Par Pharmaceutical, Inc. et al v. Amneal Pharmaceuticals of New York, LLC, et al., 6 patentsANDA 211857Vasopressin | D. Del. | 2018-12-20 | Terminated 2022-02-09 | — |
| D.N.J. | 2018-10-11 | Terminated 2020-06-24 | — | |
Athenex Pharma Solutions, LLC et al v. Par Pharmaceutical, Inc. et al 6 patentsvasopressin | NYWD | 2018-08-13 | Terminated 2019-07-10 | — |
Par Pharmaceutical, Inc. et al v. Eagle Pharmaceuticals, Inc. 6 patentsANDA 211538Vasopressin | D. Del. | 2018-05-31 | Terminated 2021-09-16 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 Labeling for the RLD, Vasostrict® (Vasopressin Injection USP), ... FDA-2020-P-2077 The Weinberg Group LLC filed a suitability petition regarding Vasostrict (Vasopressin Injection USP), 20 Units/mL, the reference listed drug approved under NDA 204485. The petition addresses the suitability of the reference labeling for use in evaluating generic ANDA applications for vasopressin inj | Suitability | 2020-10-15 | Open | The Weinberg Group LLC |
Suitability Petition from The Weinberg Group LLC FDA-2020-P-2077 The Weinberg Group LLC filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Vasopressin Injection USP in strengths of 50 units/2.5 mL and 100 units/5 mL suitable for submission in an Abbreviated New Drug Application, w | Suitability | 2020-10-15 | Open | The Weinberg Group LLC |
Attachment 3 Proposed Prescribing Information for Vasopressin Injection USP, ... FDA-2020-P-2077 This document contains proposed prescribing information for vasopressin injection in two formulations (50 units/2.5 mL and 100 units/5 mL single dose vials) submitted by The Weinberg Group LLC as part of a suitability petition to the FDA regarding the appropriate regulatory pathway and requirements | Suitability | 2020-10-15 | Open | The Weinberg Group LLC |
Attachment 2 Labeling for the RLD, Vasostrict® (Vasopressin Injection USP), 2... FDA-2020-P-1766 The Weinberg Group LLC filed a suitability petition regarding Vasostrict (Vasopressin Injection USP), 20 Units/mL, approved under NDA 204485, requesting FDA evaluation of the reference listed drug's labeling suitability for use as a reference standard for generic vasopressin injection applications. | Suitability | 2020-08-18 | Open | The Weinberg Group LLC |
Suitability Petition from The Weinberg Group LLC FDA-2020-P-1766 The Weinberg Group LLC filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Vasopressin Injection USP in strengths of 50 units/2.5 mL and 100 units/5 mL suitable for submission as an ANDA, referencing Par Sterile Produ | Suitability | 2020-08-18 | Open | The Weinberg Group LLC |
Attachment 3 Proposed Prescribing Information for Vasopressin Injection USP, ... FDA-2020-P-1766 The Weinberg Group LLC filed a suitability petition requesting FDA approval of proposed prescribing information for vasopressin injection USP in two formulations: 50 units/2.5 mL and 100 units/5 mL in single dose vials. The petition seeks to establish the suitability of these vasopressin injection p | Suitability | 2020-08-18 | Open | The Weinberg Group LLC |
Suitability Petition from AuroMedics Pharma LLC on behalf of Aurobindo Pharma... FDA-2019-P-3934 AuroMedics Pharma LLC on behalf of Aurobindo Pharma Ltd filed this section 505(j)(2)(C) ANDA suitability petition requesting FDA permission to submit an ANDA for vasopressin injection with a total drug content of 200 units in a 10 mL multiple dose vial at a concentration of 20 units per mL, based on | Suitability | 2019-08-21 | Open | AuroMedics Pharma LLC on behalf of Aurobindo Pharma Ltd |
Source: Regulations.gov. FDA citizen petitions matched by application number.