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DEXMEDETOMIDINE HYDROCHLORIDE

ANDA

DEXMEDETOMIDINE HYDROCHLORIDE | A208129 | FRESENIUS KABI USA LLC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: PRECEDEX(TE code: AP)

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Hospira, Inc. v. Fresenius Kabi USA, LLC 1:2017cv07903 1 patentANDA 208129dexmedetomidine hydrochloride	N.D. Ill.	2017-11-01	Terminated 2018-12-17	—
Hospira, Inc. v. Fresenius Kabi USA, LLC 1:2016cv00651 4 patentsANDA 208129dexmedetomidine hydrochloride	N.D. Ill.	2016-01-15	Terminated 2018-12-17	—

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

API Supply Chain16 active DMFs1 inactive

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

FERMION OYDEXMEDETOMIDINE HYDROCHLORIDE

DMF 138101998

STERLING WISCONSIN LLCDEXMEDETOMIDINE HYDROCHLORIDE USP (FP-071)

DMF 226812009

GLAND PHARMA LTDDEXMEDETOMIDINE HYDROCHLORIDE USP

DMF 232322009

ASYMCHEM LABORATORIES TIANJIN CO LTDDEXMEDETOMIDINE HYDROCHLORIDE

DMF 262232012

JIANGSU HENGRUI PHARMACEUTICALS CO LTDDEXMEDETOMIDINE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG SUBSTANCE

DMF 263772012

INTERQUIM SA DE CVDEXMEDETOMIDINE HYDROCHLORIDE

DMF 278832014

EMCURE PHARMACEUTICALS LTDDEXMEDETOMIDINE HYDROCHLORIDE USP

DMF 280782014

GLAND PHARMA LTDDEXMEDETOMIDINE HYDROCHLORIDE USP

DMF 286082014

MOEHS IBERICA SLDEXMEDETOMIDINE HYDROCHLORIDE

DMF 334042018

MOEHS IBERICA SLDEXMEDETOMIDINE HYDROCHLORIDE

DMF 364782022

GUANG'AN KINGDAY PHARMA AND CHEM CO LTDDEXMEDETOMIDINE HYDROCHLORIDE

DMF 366812022

ASCENSUS SPECIALTIES LLCDEXMEDETOMIDINE HYDROCHLORIDE USP

DMF 382482023

MAITHRI DRUGS PRIVATE LTDDEXMEDETOMIDINE HYDROCHLORIDE USP

DMF 387612023

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDDEXMEDETOMIDINE HYDROCHLORIDE NON-STERILE DRUG SUBSTANCE

DMF 397752024

JIANGSU CHIA TAI FENGHAI PHARMACEUTICAL CO LTDDEXMEDETOMIDINE HYDROCHLORIDE

DMF 407512024

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDDEXMEDETOMIDINE HYDROCHLORIDE USP

DMF 426572025

ORION CORP LTDInactiveDEXMEDETOMIDINE

DMF 92511991

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 20, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Nov 29, 2018

No patent or exclusivity listings for this strength.

#002 — EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Nov 29, 2018

#003 — EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Nov 29, 2018