Norepinephrine bitartrate - Generic Drug Details

What are the generic drug sources for norepinephrine bitartrate and what is the scope of patent protection?

Norepinephrine bitartrate is the generic ingredient in five branded drugs marketed by Hospira, Amneal, Baxter Hlthcare Corp, Breckenridge, Caplin, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Meitheal, Metrics Pharm, Mylan Labs Ltd, Rising, Sandoz, Sun Pharm, Zydus Pharms, Inforlife, Long Grove Pharms, and Eastman Kodak, and is included in twenty NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Norepinephrine bitartrate has six patent family members in three countries.

There are five drug master file entries for norepinephrine bitartrate. Twenty-two suppliers are listed for this compound.

Summary for norepinephrine bitartrate

International Patents:	6
US Patents:	8
Tradenames:	5
Applicants:	18
NDAs:	20
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	9
Patent Applications:	7
Drug Prices:	Drug price trends for norepinephrine bitartrate
What excipients (inactive ingredients) are in norepinephrine bitartrate?	norepinephrine bitartrate excipients list
DailyMed Link:	norepinephrine bitartrate at DailyMed

See drug prices for norepinephrine bitartrate

Recent Clinical Trials for norepinephrine bitartrate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Alberta	Phase 4
Tunis University	Phase 4
Second Affiliated Hospital, School of Medicine, Zhejiang University	N/A

See all norepinephrine bitartrate clinical trials

Pharmacology for norepinephrine bitartrate

Drug Class

Catecholamine

Medical Subject Heading (MeSH) Categories for norepinephrine bitartrate

Adrenergic alpha-Agonists

Sympathomimetics

Vasoconstrictor Agents

Anatomical Therapeutic Chemical (ATC) Classes for norepinephrine bitartrate

A01AD	Other agents for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

B02BC	Local hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03AA	Alpha- and beta-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01EA	Sympathomimetics in glaucoma therapy
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for norepinephrine bitartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Meitheal	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	040455-001	Mar 3, 2003	AP	RX	No	No
Hikma	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	203662-001	Nov 7, 2018	AP	RX	No	No
Fresenius Kabi Usa	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	211382-001	Nov 3, 2020	AP	RX	No	No
Hikma	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	040462-001	Oct 31, 2003	AP	RX	No	No
Amneal	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	210839-001	Dec 17, 2018	AP	RX	No	No
Inforlife	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	215700-003	Sep 15, 2022		RX	Yes	Yes			Y
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-001	Oct 6, 2022		RX	Yes	Yes			Y

International Patents for norepinephrine bitartrate

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2021178946
World Intellectual Property Organization (WIPO)	2018140894
European Patent Office	4114336	SYSTÈME DE RÉCIPIENT SCELLÉ CONDITIONNÉ DE STOCKAGE STABLE DE FORMULATION PHARMACEUTIQUE SENSIBLE À L'OXYGÈNE (PACKAGED, SEALED CONTAINER SYSTEM FOR STABLE STORAGE OF AN OXYGEN SENSITIVE PHARMACEUTICAL FORMULATION)
World Intellectual Property Organization (WIPO)	2020217079
Canada	3051467	COMPOSITIONS DE NOREPINEPHRINE ET PROCEDES ASSOCIES (NOREPINEPHRINE COMPOSITIONS AND METHODS THEREFOR)
Canada	3174640	SYSTEME DE RECIPIENT SCELLE CONDITIONNE DE STOCKAGE STABLE DE FORMULATION PHARMACEUTIQUE SENSIBLE A L'OXYGENE (PACKAGED, SEALED CONTAINER SYSTEM FOR STABLE STORAGE OF AN OXYGEN SENSITIVE PHARMACEUTICAL FORMULATION)