Viewing data from:

ISUPREL

NDA

ISOPROTERENOL HYDROCHLORIDE | N006328 | SANOFI AVENTIS US LLC

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

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 E. Rust Consulting LLC FDA-2023-P-4636 · 4 docket documents E. Rust Consulting LLC filed this citizen petition requesting that the FDA determine whether ISUPREL (isoproterenol hydrochloride) injection, 0.2 mg/mL, NDA Number N010515, held by Bausch Health US LLC, was voluntarily withdrawn from the commercial market for reasons of safety or efficacy, or for co	505(q)	2023-10-20	Granted	E. Rust Consulting LLC

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

Clinical Trials

13 trials from ClinicalTrials.gov — 1 recruiting, 10 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Autoimmune Basis for Postural Tachycardia Syndrome NCT02725060	N/A	By Invitation	Vanderbilt University Medical Center	58	2016-02 → 2026-12
Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol NCT02286934	Phase 1	Completed	Seoul National University Hospital	24	2014-09 → 2014-12
Adenosine to Assess Complete Conduction Block During Catheter Ablation of Paroxysmal Atrial Fibrillation NCT03032965	Phase 2	Completed	University of Michigan	131	2011-10 → 2015-07
Measurement of Bispectral Index and Awareness in Patients Undergoing Electrophysiology Studies With Isoproterenol NCT01377636	N/A	Completed	NYU Langone Health	20	2009-08 → 2011-10
Decision Support for Intraoperative Low Blood Pressure NCT02726620	N/A	Completed	Vanderbilt University Medical Center	22,435	2017-01-05 → 2018-12-29
Vascular Response to Isoproterenol and β2 Adrenergic Receptor Polymorphisms NCT00226551	N/A	Completed	Hadassah Medical Organization	100	1999-08
Chronotropic Incompetence in Patients With HFpEF NCT02524145	N/A	Completed	University of Texas Southwestern Medical Center	40	2015-06 → 2017-11-15
Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract NCT00428428	Phase 2/3	Completed	Fredericia Hosptial	12	2007-02 → 2007-11
The Pathophysiology of Orthostatic Hypotension NCT00748059	Phase 1	Completed	Vanderbilt University Medical Center	10	1996-12 → 2020-12
Neural Basis of Meal Related Interoceptive Dysfunction in Anorexia Nervosa NCT02615119	N/A	Completed	Laureate Institute for Brain Research, Inc.	97	2015-10-01 → 2023-06

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

API Supply Chain11 active DMFs4 inactive

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

HOSPIRA INCISOPROTERENOL HYDROCHLORIDE DRUG SUBSTANCE

DMF 252122011

STERLING WISCONSIN LLCISOPROTERENOL HYDROCHLORIDE USP

DMF 274692013

MICRO LABS LTDISOPROTERENOL HYDROCHLORIDE USP

DMF 297322015

AMPHASTAR NANJING PHARMACEUTICALS INCISOPROTERENOL HYDROCHLORIDE USP

DMF 298762015

HARMAN FINOCHEM LTDISOPROTERENOL HYDROCHLORIDE USP

DMF 307072016

BIOPHORE INDIA PHARMACEUTICALS PVT LTDISOPROTERENOL HYDROCHLORIDE

DMF 308112016

EDMOND PHARMA SRLISOPROTERENOL HYDROCHLORIDE

DMF 315692017

APITORIA PHARMA PRIVATE LTDISOPROTERENOL HYDROCHLORIDE

DMF 319302017

EMCURE PHARMACEUTICALS LTDISOPROTERENOL HYDROCHLORIDE USP

DMF 321512017

GLAND PHARMA LTDISOPROTERENOL HYDROCHLORIDE

DMF 334452019

DEVA HOLDING ASISOPROTERENOL HYDROCHLORIDE USP

DMF 366342022

SUMIKA FINE CHEMICALS CO LTDInactiveISOPROTERENOL HYDROCHLORIDE USP XX

DMF 51321983

BOEHRINGER INGELHEIM PHARMA KGInactiveISOPROTERENOL HYDROCHLORIDE

DMF 89011990

SAI LIFE SCIENCES LTDInactiveISOPROTERENOL HYDROCHLORIDE USP

DMF 297172015

SUNNY PHARMTECH INCInactiveISOPROTERENOL HYDROCHLORIDE USP

DMF 319272018

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

Products (2)

Sort:

#001 — 10MG

0 patents0 exclusivities▴

TABLET;RECTAL, SUBLINGUAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 15MG

0 patents0 exclusivities▾

TABLET;RECTAL, SUBLINGUAL | Approved: Approved Prior to Jan 1, 1982