NOREPINEPHRINE BITARTRATE - Generic Drug Details

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What are the generic 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. Twenty-two suppliers are listed for this compound.

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

Sponsor

Phase

University of Alberta

Phase 4

Tunis University

Phase 4

Second Affiliated Hospital, School of Medicine, Zhejiang University

N/A

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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
Amneal	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	210839-001	Dec 17, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-003	Oct 6, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-003	Oct 6, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Metrics Pharm	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	040522-001	Sep 30, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Inforlife	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	215700-003	Sep 15, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Gland Pharma Ltd	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	214323-001	May 6, 2021	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Caplin	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	217575-001	Sep 15, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Country	Patent Number	Title	Estimated Expiration
Canada	3051467	COMPOSITIONS DE NOREPINEPHRINE ET PROCEDES ASSOCIES (NOREPINEPHRINE COMPOSITIONS AND METHODS THEREFOR)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2020217079		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2018140894		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Country

Patent Number

Title

Estimated Expiration

Canada

3051467

COMPOSITIONS DE NOREPINEPHRINE ET PROCEDES ASSOCIES (NOREPINEPHRINE COMPOSITIONS AND METHODS THEREFOR)

World Intellectual Property Organization (WIPO)

2020217079

World Intellectual Property Organization (WIPO)

2018140894

>Country

>Patent Number

>Title

>Estimated Expiration

International Patents:	3
US Patents:	7
Tradenames:	5
Applicants:	17
NDAs:	19
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	9
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