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VASOPRESSIN

NDA

VASOPRESSIN | N212593 | AMERICAN REGENT INC

2 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Par Pharmaceutical, Inc. et al v. American Regent, Inc. 1:2019cv01490 4 patentsvasopressin	D. Del.	2019-08-09	Terminated 2020-05-21	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain7 active DMFs1 inactive

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

BCN PEPTIDES SAVASOPRESSIN

DMF 257362012

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
Aug 4, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20UNITS/ML (20UNITS/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Aug 3, 2020

No patent or exclusivity listings for this strength.

#002 — 200UNITS/10ML (20UNITS/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jun 9, 2023