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VASOPRESSIN IN SODIUM CHLORIDE 0.9%

NDA

VASOPRESSIN | N217569 | BAXTER HEALTHCARE CORP

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

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Today

12447190

Sep. 27, 2044

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Endo USA, Inc. and Endo Operations Limited v. Baxter Healthcare Corporation 1:2023cv00358 3 patentsvasopressin	D. Del.	2023-03-29	Terminated 2025-02-13	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

3 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Fresenius Kabi USA, LLC FDA-2024-P-4135 · 4 docket documents Fresenius Kabi USA, LLC filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an abbreviated new drug application for Vasopressin in 0.9% Sodium Chloride Injection 50 units per 50 mL (1 unit/mL) in a single dose ready	Suitability	2024-08-29	Denied	Fresenius Kabi USA, LLC
Attachment 3 Proposed Prescribing Information for Vasopressin Injection USP, ... FDA-2020-P-2077 · 5 docket documents 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 3 Proposed Prescribing Information for Vasopressin Injection USP, ... FDA-2020-P-1766 · 6 docket documents 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 The petition seeks to establish the suitability of these vasopressin injection p	Suitability	2020-08-18	Withdrawn	The Weinberg Group LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

62 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 45 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Vasopressin and Pain Perception in the Brain NCT03446456	Phase 1/2	Active	University of Maryland, Baltimore	40	2018-09-17 → 2026-12-31
Effects of Ephedrine, Phenylephrine, Norepinephrine and Vasopressin on Contractility of Human Myometrium and Umbilical Vessels: An In-vitro Study NCT04053478	N/A	Recruiting	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	144	2019-07-08 → 2026-12
Vasoactive Drugs in Intensive Care Unit NCT02118467	Phase 4	Recruiting	University of Chicago	836	2014-05-15 → 2026-12-01
AVERT Shock: Arginine Vasopressin During the Early Resuscitation of Traumatic Shock NCT01611935	Phase 2	Completed	University of Pennsylvania	101	2013-05-01 → 2016-09-06
Vasopressin and V2 Receptor in Meniere's Disease NCT00599560	N/A	Completed	Osaka University	135	1998-04 → 2005-09
Study of the Use of Misoprostol to Decrease Bleeding During a Myomectomy NCT01700478	Phase 4	Completed	University Hospital of the West Indies	45	2005-02 → 2005-04
Optimal VAsopressor titraTION Pilot Randomized Controlled Trial NCT01800877	N/A	Completed	Francois Lamontagne	120	2013-04 → 2015-02
Optimization of Hepatic Hemodynamics During Liver Surgery NCT02993640	Early Phase 1	Completed	Sahlgrenska University Hospital	13	2016-09 → 2017-03-20
Comparison of the Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy: A Randomized, Placebo Controlled Trial NCT00799292	Phase 4	Completed	Ascher-Walsh, Charles, M.D.	58	2004-01 → 2005-01
Intranasal Vasopressin Treatment in Children With Autism NCT03204786	Phase 2/3	Completed	Stanford University	157	2018-02-20 → 2024-03-18

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$442.02

Highest Price

$851.92

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00338-9647-12VASOPRESSIN IN 0.9 % SOD CHLORIDE	$851.92	FSS	Baxter Healthcare Corporation	08/14/2026
00338-9640-12VASOPRESSIN IN 0.9 % SOD CHLORIDE	$442.02	FSS	Baxter Healthcare Corporation	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain8 active DMFs1 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

BCN PEPTIDES SAVASOPRESSIN

DMF 257362012

BACHEM AMERICAS INCVASOPRESSIN, USP (BULK)

DMF 285322014

POLYPEPTIDE LABORATORIES SWEDEN ABVASOPRESSIN

DMF 321162017

PIRAMAL PHARMA LTDVASOPRESSIN USP

DMF 321462017

INTERNATIONAL MEDICATION SYSTEMS LTDVASOPRESSIN USP

DMF 327692018

AURO PEPTIDES LTDVASOPRESSIN USP

DMF 331192018

HAINAN SHUANGCHENG PHARMACEUTICALS CO LTDVASOPRESSIN USP

DMF 376342022

HETERO DRUGS LTDVASOPRESSIN USP

DMF 420732025

POLYPEPTIDE LABORATORIES SWEDEN ABInactiveVASOPRESSIN

DMF 275772013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 25, 2025	SUPPL -3	View Letter (PDF)
Oct 3, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20UNITS/100ML (0.2UNITS/ML)

RLD

1 patent0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Sep 29, 2023

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
12447190	Sep 27, 2044	—	—	Yes	—	—

#002 — 40UNITS/100ML (0.4UNITS/ML)

RLD

1 patent0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Sep 29, 2023