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DOBUTREX

NDA

DOBUTAMINE HYDROCHLORIDE | N017820 | ELI LILLY AND CO

1 strength0 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Cardinal Health Regulatory Sciences FDA-2020-P-1650 · 4 docket documents Cardinal Health Regulatory Sciences filed this citizen petition pursuant to Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether DOBUTREX (Dobutamine hydrochloride), EQ 12.5 MG BASE/ML, held by Eli Lilly and Co., was voluntarily withdrawn from sale for	505(q)	2020-07-10	Granted	Cardinal Health Regulatory Sciences

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

Clinical Trials

60 trials from ClinicalTrials.gov, 36 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Cardiac Allograft Vasculopathy and Dobutamine Stress Echocardiography / Brain Natriuretic Peptide Coupling NCT00384540	N/A	Completed	University Hospital, Strasbourg, France	53	2006-09 → 2016-12-20
Furosemide Stress Test Guiding Initiation of Renal Replacement Therapy NCT02730117	N/A	Completed	Chulalongkorn University	118	2016-03 → 2017-07
The Effects of Levosimendan During Mitral Valve Surgery NCT01969071	Phase 4	Completed	Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital	140	2009-07 → 2013-09
Early Diagnosis of Diastolic Dysfunction and Reliability of DSE in Detecting Stress Diastolic Dysfunction NCT00998205	N/A	Completed	University of Missouri-Columbia	16	2008-06 → 2011-01
Decision Support for Intraoperative Low Blood Pressure NCT02726620	N/A	Completed	Vanderbilt University Medical Center	22,435	2017-01-05 → 2018-12-29
Low-Dose Dobutamine Tc-99m-Mibi Gated SPECT to Predict Left Ventricular Remodelling in Patients Reperfused in the Acute Phase of MI NCT00487812	N/A	Completed	University Hospital, Clermont-Ferrand	50	2004-12 → 2008-09
The Effects of Glucocorticoids on Mortality and Renal Function in Patients With Acute Decompensated Heart Failure NCT00953303	Phase 2/3	Completed	Hebei Medical University	102	2009-01 → 2012-01
Influence of Continuous Administration of Phenylephrine Versus Dobutamine on Spinal Oxygen Saturation, Measured With Near-infrared Spectroscopy (NIRS).NCT03846765	Phase 4	Completed	University Hospital, Ghent	36	2019-07-04 → 2022-11-10
Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot NCT00557934	N/A	Completed	University Hospital Tuebingen	16	2007-10 → 2008-09
Timing of Complete Revascularization for Multivessel Coronary Artery Disease in STEMI NCT02756000	N/A	Completed	Clinical Hospital Center Zemun	120	2016-01 → 2018-11

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

API Supply Chain5 active DMFs8 inactive

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

CHEMWERTH INCDOBUTAMINE HYDROCHLORIDE

DMF 88561990

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPADOBUTAMINE HYDROCHLORIDE

DMF 97621992

SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBHDOBUTAMINE HYDROCHLORIDE

DMF 110231994

HAINAN POLY PHARM CO LTDDOBUTAMINE HYDROCHLORIDE USP

DMF 352172020

ARAGEN LIFE SCIENCES LTDDOBUTAMINE HYDROCHLORIDE

DMF 426022025

ABBOTT LABORATORIESInactiveDOBUTAMINE HYDROCHLORIDE

DMF 85891990

RAYLO CHEMICALSInactiveDOBUTAMINE HYDROCHLORIDE

DMF 90241991

SUMIKA FINE CHEMICALS CO LTDInactiveDOBUTAMINE HYDROCHLORIDE

DMF 93691991

BIOCHIMICA OPOS 2 SPAInactiveDOBUTAMINE HYDROCHLORIDE, BULK, NON STERILE PYROGEN FREE

DMF 94831992

HUHTAMAKI OY LEIRAS PHARMACEUTICALSInactiveDOBUTAMINE HYDROCHLORIDE

DMF 98881992

EGIS PHARMACEUTICALS PRIVATE LTDInactiveDOBUTAMINE HYDROCHLORIDE

DMF 100971993

CHEMSYN SCIENCE LABORATORIESInactiveDOBUTAMINE HYDROCHLORIDE

DMF 102961993

IROTEC LABORATORIESInactiveDOBUTAMINE HYDROCHLORIDE

DMF 107061994

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 23, 2002	SUPPL -37	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — EQ 12.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.