NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE Drug Patent Profile

When do Norepinephrine Bitartrate In 5% Dextrose patents expire, and when can generic versions of Norepinephrine Bitartrate In 5% Dextrose launch?

Norepinephrine Bitartrate In 5% Dextrose is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. There is one patent protecting this drug.

This drug has three patent family members in three countries.

The generic ingredient in NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE is norepinephrine bitartrate. There are five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the norepinephrine bitartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Norepinephrine Bitartrate In 5% Dextrose

A generic version of NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE was approved as norepinephrine bitartrate by MEITHEAL on March 3^rd, 2003.

Summary for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

International Patents:	3
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	9
DailyMed Link:	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE at DailyMed

Recent Clinical Trials for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

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 IN 5% DEXTROSE clinical trials

Pharmacology for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

Drug Class

Catecholamine

US Patents and Regulatory Information for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE is protected by one US patents.

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 IN 5% DEXTROSE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214313-001	Jan 15, 2021		RX	Yes	Yes			Y
Baxter Hlthcare Corp	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214313-002	Jan 15, 2021		RX	Yes	Yes			Y
Baxter Hlthcare Corp	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214313-003	Nov 21, 2023		RX	Yes	Yes			Y

International Patents for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

See the table below for patents covering NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2021178946
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)
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)

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Norepinephrine Bitartrate in 5% Dextrose Injection

Introduction

Norepinephrine Bitartrate in 5% Dextrose Injection is a critical medication used to restore and maintain blood pressure in patients experiencing severe, acute hypotension. This article delves into the market dynamics and financial trajectory of this drug, highlighting key trends, drivers, and projections.

Market Size and Growth

The market for norepinephrine drugs, including Norepinephrine Bitartrate in 5% Dextrose Injection, is experiencing robust growth. As of 2023, the norepinephrine drug market was valued at USD 388.4 million and is projected to reach USD 871.9 million by 2031, growing at a compound annual growth rate (CAGR) of 12.2% from 2024 to 2031[3].

Key Drivers of Market Growth

Several factors are driving the growth of the norepinephrine drug market:

Increasing Prevalence of Cardiovascular Illnesses and Sepsis

The rising rates of cardiovascular diseases and sepsis are significant drivers. Norepinephrine is a vital medication in treating shock and severe hypotension resulting from these conditions[3].

Advancements in Critical Care Management

Improvements in medical emergency response systems and critical care units are enhancing the rapid administration and management of shock situations, thereby increasing the demand for norepinephrine[3].

Expanding Healthcare Infrastructure

Investments in intensive care units and the growing access to essential drugs, including norepinephrine, are contributing to market growth[3].

Clinical Research and Development

Ongoing clinical research aimed at enhancing dosage schedules and broadening indications is improving the therapeutic efficacy and safety profile of norepinephrine, further propelling its market expansion[3].

Market Segmentation

The norepinephrine drug market is segmented based on type (Norepinephrine Bitartrate, Norepinephrine Hydrochloride) and application (Septic Shock, Hypotension), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[3].

Product Innovations

Baxter International Inc.'s introduction of the premix Norepinephrine Bitartrate in 5% Dextrose Injection is a notable innovation. This product is the first and only FDA-approved, ready-to-use premix norepinephrine in dextrose, which reduces the risk of medication errors due to compounding and minimizes wait times for drug administration[1][4].

Indications and Usage

Norepinephrine Bitartrate in 5% Dextrose Injection is indicated for the restoration and maintenance of blood pressure in adult patients with severe, acute hypotension resulting from various causes such as surgery, trauma, hemorrhage, myocardial infarction, and septicemia. It is also useful as an adjunct in the treatment of cardiac arrest and profound hypotension[2][4].

Storage and Administration

The premix formulation by Baxter allows for room temperature storage, making it readily available near the point of care. The product is distinctly labeled and barcoded, differentiating product strengths to minimize errors[4].

Risk Information and Contraindications

While norepinephrine bitartrate is effective, it comes with several risks and contraindications. It should not be given to patients who are hypotensive from blood volume deficits except as an emergency measure. Continuous administration without blood volume replacement can lead to severe cardiogenic shock, arrhythmias, and other complications. It should be used with caution in patients receiving monoamine oxidase (MAO) inhibitors or certain antidepressants[2][4].

Financial Projections

Given the strong growth drivers, the financial trajectory for norepinephrine bitartrate in 5% dextrose injection is promising. The market's CAGR of 12.2% from 2024 to 2031 indicates significant revenue growth, making it an attractive segment for pharmaceutical companies and investors[3].

Competitive Landscape

Major companies operating in the dextrose and norepinephrine markets are focusing on product innovations and collaborations to maintain their market position. Baxter International Inc.'s premix formulation is a prime example of this trend, highlighting the competitive efforts to provide convenient, error-reducing, and effective solutions[1].

Conclusion

The market for Norepinephrine Bitartrate in 5% Dextrose Injection is poised for substantial growth driven by increasing demand for effective vasopressor treatments, advancements in critical care, and expanding healthcare infrastructure. As the prevalence of cardiovascular illnesses and sepsis continues to rise, the financial trajectory of this drug is expected to remain robust.

Key Takeaways

• The norepinephrine drug market is projected to grow from USD 388.4 million in 2023 to USD 871.9 million by 2031.
• Key drivers include the increasing prevalence of cardiovascular illnesses and sepsis, advancements in critical care, and expanding healthcare infrastructure.
• Product innovations, such as Baxter's premix formulation, are reducing medication errors and wait times.
• The drug is indicated for severe, acute hypotension and is used as an adjunct in cardiac arrest and profound hypotension.
• It comes with significant risk information and contraindications that must be carefully managed.

FAQs

Q: What is the primary indication for Norepinephrine Bitartrate in 5% Dextrose Injection? A: The primary indication is to raise blood pressure in adult patients with severe, acute hypotension resulting from various causes such as surgery, trauma, and septicemia[2][4].

Q: What are the key drivers of the norepinephrine drug market growth? A: The key drivers include the increasing prevalence of cardiovascular illnesses and sepsis, advancements in critical care management, and expanding healthcare infrastructure[3].

Q: What is the projected market size of the norepinephrine drug market by 2031? A: The market is expected to reach USD 871.9 million by 2031, growing at a CAGR of 12.2% from 2024 to 2031[3].

Q: What are the risks associated with continuous administration of Norepinephrine Bitartrate in 5% Dextrose Injection without blood volume replacement? A: Continuous administration without blood volume replacement can lead to severe cardiogenic shock, arrhythmias, and other complications such as decreased renal perfusion and cardiac arrhythmias[2].

Q: How does Baxter's premix formulation of Norepinephrine Bitartrate in 5% Dextrose Injection improve patient care? A: Baxter's premix formulation reduces the risk of medication errors due to compounding, minimizes wait times for drug administration, and allows for room temperature storage near the point of care[4].

Sources

1. The Business Research Company, Global Dextrose Market Report 2024.
2. Health Canada, PRESCRIBING INFORMATION NOREPINEPHRINE BITARTRATE in 5% DEXTROSE INJECTION.
3. Market Research Intellect, Norepinephrine Drug Market Size and Projections.
4. Baxter, Norepinephrine Bitartrate in 5% Dextrose Injection.