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LEVOPHED

NDA

NOREPINEPHRINE BITARTRATE | N007513 | HOSPIRA INC

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 (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from TechReg Services, Inc. FDA-2019-P-2070 · 2 docket documents TechReg Services, Inc. submitted this suitability petition under 21 CFR §314.93 and section 505(j)(2)(c) of the FD&C Act requesting FDA determination of whether 8 mL and 16 mL fill volumes of Norepinephrine Bitartrate Injection, USP are suitable for inclusion in an ANDA, with the reference listed dr	Other	2019-05-01	Open	TechReg Services, Inc.

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

Clinical Trials

93 trials from ClinicalTrials.gov — 4 recruiting, 1 active, 58 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Caveolin-1 and Vascular Dysfunction NCT01426529	Phase 1	Active	Brigham and Women's Hospital	120	2010-10-01 → 2026-10-15
Targeted Blood-pressure Management and Acute Kidney Injury After Coronary Artery Bypass Surgery NCT03629418	N/A	Recruiting	Peking University First Hospital	612	2018-08-14 → 2026-07
: Vascular Function in Health and Disease NCT02966665	Phase 1	Recruiting	Russell Richardson	420	2008-09 → 2026-08
Vasoactive Drugs in Intensive Care Unit NCT02118467	Phase 4	Recruiting	University of Chicago	836	2014-05-15 → 2026-12-01
Effects of Ephedrine, Phenylephrine, Norepinephrine and Vasopressin on Contractility of Human Myometrium and Umbilical Vessels: An In-vitro Study NCT04053478	N/A	Recruiting	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	144	2019-07-08 → 2026-12
The Effect of Vasopressors on Cerebral Oxygentaion During Off Pump CABG NCT04214145	N/A	Completed	Seoul National University Hospital	90	2020-01-07 → 2021-09-03
The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section NCT03833895	Phase 2/3	Completed	China International Neuroscience Institution	238	2019-02-20 → 2019-09-02
Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock NCT00604019	Phase 3	Completed	Rush University Medical Center	252	2003-03 → 2009-08
Weaning of Norepinephrine Guided by the Dynamic Arterial Compliance in Cardiac Surgery Post Operative.NCT02479529	Phase 3	Completed	Centre Hospitalier Universitaire, Amiens	130	2014-10 → 2016-06
Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis NCT03434028	Phase 3	Completed	Massachusetts General Hospital	1,563	2018-03-07 → 2022-08-24

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$14.67

Highest Price

$45.23

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00409-3375-04LEVOPHED 1MG/ML INJ 4ML AMP	$45.23	FSS	Pfizer Inc.	06/30/2029
00409-3375-04LEVOPHED 1MG/ML INJ 4ML AMP	$14.67	Big4	Pfizer Inc.	06/30/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain6 active DMFs1 inactive

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

CHEMPACIFIC CORPNOREPINEPHRINE BITARTRATE

DMF 163442002

CURIA NEW YORK INCNOREPINEPHRINE BITARTRATE, USP

DMF 295622015

HARMAN FINOCHEM LTDNOREPINEPHRINE BITARTRATE USP

DMF 331272018

SUN PHARMACEUTICAL INDUSTRIES LTDNOREPINEPHRINE BITARTRATE USP

DMF 351842021

ZHEJIANG BOXIAO BIOPHARMACEUTICAL CO LTDNOREPINEPHRINE BITARTRATE (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 400172024

MOEHS IBERICA SLNOREPINEPHRINE BITARTRATE

DMF 437962026

WUHAN WUYAO PHARMACEUTICAL CO LTDInactiveNOREPINEPHRINE BITARTRATE USP, NON-STERILE, BULK DRUG

DMF 153672001

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Oct 23, 2020	SUPPL -45	View Letter (PDF)
Jun 17, 2020	SUPPL -38	View Letter (PDF)
Oct 4, 2007	SUPPL -24	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1MG BASE/ML

RLDAP

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.