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VASOPRESSIN IN SODIUM CHLORIDE 0.9%

NDA

VASOPRESSIN | N217766 | LONG GROVE PHARMACEUTICALS LLC

3 strengths0 unique patents0 unique exclusivities

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Fresenius Kabi USA, LLC FDA-2026-P-0525 · 5 docket documents Fresenius Kabi USA, LLC filed this petition pursuant to 21 CFR § 10.30 and § 314.161 requesting that the FDA Commissioner determine whether Long Grove Pharmaceuticals, LLC has withdrawn Vasopressin Sodium Chloride 0.9%, 50 units/50 mL (NDA 217766) for reasons of safety or efficacy, as the product no	505(q)	2026-01-16	Granted	Fresenius Kabi USA, LLC
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

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

$172.92

Highest Price

$396.98

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
81298-8554-03VASOPRESSIN 0.4UNT/ML/NACL INJ,BAG,100ML	$396.98	FSS	Long Grove Pharmaceuticals, LLC	03/31/2028
81298-8552-03VASOPRESSIN 0.2 UNIT/ML/NACL INJ,100ML	$172.92	FSS	Long Grove Pharmaceuticals, LLC	03/31/2028

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

1 letter from Drugs@FDA

Date	Submission	Document
Jul 15, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 20UNITS/100ML (0.2UNITS/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jul 11, 2024

No patent or exclusivity listings for this strength.

#002 — 40UNITS/100ML (0.4UNITS/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jul 11, 2024

#003 — 50UNITS/50ML (1UNIT/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jul 11, 2024