NOREPINEPHRINE BITARTRATE - Generic Drug Details

What are the generic sources for norepinephrine bitartrate and what is the scope of freedom to operate?

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, Sandoz, Sun Pharm, Zydus Pharms, Inforlife, Long Grove Pharms, and Eastman Kodak, and is included in nineteen NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Norepinephrine bitartrate has three patent family members in two countries.

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

Summary for NOREPINEPHRINE BITARTRATE

International Patents:	3
US Patents:	7
Tradenames:	5
Applicants:	17
NDAs:	19
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	8
Patent Applications:	7
Formulation / Manufacturing:	see details
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
Tunis University	Phase 4
Second Affiliated Hospital, School of Medicine, Zhejiang University	N/A
Wright State University	Phase 3

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

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
Baxter Hlthcare Corp	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	040859-001	Mar 27, 2012	AP	RX	No	No
Caplin	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	217575-001	Sep 15, 2023	AP	RX	No	No
Zydus Pharms	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	216341-001	Jul 19, 2022		DISCN	No	No
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-002	Oct 6, 2022		RX	Yes	Yes			Y
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-003	Oct 6, 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)	2018140894
Canada	3051467
Canada	3051467	NOREPINEPHRINE COMPOSITIONS AND METHODS THEREFOR
World Intellectual Property Organization (WIPO)	2020217079