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Last Updated: April 19, 2024

Norepinephrine bitartrate - Generic Drug Details

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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, 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. Nineteen 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:	19
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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Metrics Pharm	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	040522-001	Sep 30, 2004		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Baxter Hlthcare Corp	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214313-002	Jan 15, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-002	Oct 6, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-001	Oct 6, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for norepinephrine bitartrate

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Country	Patent Number	Title	Estimated Expiration
Canada	3051467	NOREPINEPHRINE COMPOSITIONS AND METHODS THEREFOR	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2018140894		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2020217079		⤷ Try a Trial
Canada	3051467		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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