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VASOPRESSIN

ANDA

VASOPRESSIN | A217987 | CIPLA LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: VASOSTRICT(TE code: AP)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
PAR PHARMACEUTICAL, INC. et al v. CIPLA LIMITED et al 2:2023cv01150 8 patentsANDA 217987Vasopressin	D.N.J.	2023-02-28	Terminated 2023-04-27	—

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

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
Jan 31, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20UNITS/100ML (0.2UNITS/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Dec 6, 2023

No patent or exclusivity listings for this strength.