NOREPINEPHRINE BITARTRATE - Generic Drug Details

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, 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-three 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:	23
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	9
Patent Applications:	8
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
Sun Pharm	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	211980-001	Jan 29, 2021		DISCN	No	No
Sandoz	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	211359-001	Oct 18, 2018	AP	RX	No	No
Breckenridge	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	214455-001	Jan 22, 2021	AP	RX	No	No
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-001	Oct 6, 2022		RX	Yes	Yes	10,420,735		Y
Rising	NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	218758-001	May 13, 2024	AP	RX	No	No

International Patents for NOREPINEPHRINE BITARTRATE

Country	Patent Number	Title	Estimated Expiration
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)
World Intellectual Property Organization (WIPO)	2018140894

NOREPINEPHRINE BITARTRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Norepinephrine Bitartrate

Introduction

Norepinephrine bitartrate, a crucial medication in the healthcare sector, is experiencing significant growth driven by various market dynamics. This article delves into the current market size, forecasted growth, key drivers, and challenges facing the norepinephrine bitartrate market.

Market Size and Forecast

The global market for pharmaceutical-grade norepinephrine bitartrate was valued at US$ 210 million in 2023. It is anticipated to grow to US$ 301.3 million by 2030, exhibiting a Compound Annual Growth Rate (CAGR) of 5.3% during the forecast period of 2024-2030[1].

In a broader context, the norepinephrine (noradrenaline) market, which includes norepinephrine bitartrate, was valued at USD 388.4 million in 2021 and is expected to reach USD 871.6 million by 2028, with a CAGR of 12.2% during the forecast period[3][4].

Key Drivers of Market Growth

Increasing Prevalence of Cardiovascular Diseases

The rising incidence of cardiovascular diseases and conditions such as septic shock and hypotension is a significant driver of the norepinephrine bitartrate market. Norepinephrine plays a pivotal role in regulating blood pressure, making it a critical medication in these scenarios[3][4].

Aging Population

The global aging population contributes to the increased demand for norepinephrine bitartrate. Elderly individuals often require medications to address cardiovascular issues, thereby boosting the market[3].

Technological Advancements

Advancements in drug delivery systems and formulations have enhanced the efficiency and ease of administering norepinephrine bitartrate. Innovations such as sustained-release formulations improve patient compliance and provide a more controlled release of the medication[3].

Research and Development

Ongoing research and development efforts aimed at improving drug formulations and expanding the therapeutic applications of norepinephrine bitartrate are driving market growth. Emerging studies explore its potential in addressing neurodegenerative diseases and cognitive disorders[3].

Market Segmentation

By Type

The norepinephrine bitartrate market is segmented by type, primarily into purity levels such as ≥99% and <99%[1].

By Application

The primary applications of norepinephrine bitartrate include injections and other medical uses. In the broader norepinephrine market, key applications include the treatment of septic shock and hypotension[1][4].

By Geography

The market is segmented geographically into regions such as North America, Europe, Asia-Pacific, and others. Each region has its own dynamics influenced by local healthcare infrastructure, regulatory environments, and patient needs[4].

Key Players

The norepinephrine bitartrate market is dominated by several key players, including:

• CAMBREX PROFARMACO MILANO SRL
• CHEMPACIFIC CORP
• CURIA NEW YORK INC
• HARMAN FINOCHEM LTD
• SUN PHARMACEUTICAL INDUSTRIES LTD
• Suzhou Yifan Pharmaceutical
• Wuhan Wuyao Pharmaceutical
• Shanxi Zhendong Taisheng Pharmaceutical[1].

In the broader norepinephrine market, other significant players include Pfizer, Baxter International, Hospira Inc., Mylan Pharmaceuticals, and Fresenius Kabi, among others[4].

Challenges and Restraints

Regulatory Challenges

Regulatory hurdles can impede market growth. Strict regulations and approval processes can delay the introduction of new formulations and limit market expansion[3].

Supply Chain Disruptions

The COVID-19 pandemic highlighted the vulnerability of the pharmaceutical supply chain. Disruptions in supply chains can affect the availability and pricing of norepinephrine bitartrate, impacting market growth[3].

Financial Trajectory

Revenue Forecast

The norepinephrine bitartrate market is expected to grow from US$ 210 million in 2023 to US$ 301.3 million by 2030. This growth is driven by increasing demand and advancements in medical technology[1].

Investment and Funding

Increased investments in healthcare infrastructure and research and development activities are crucial for the financial trajectory of the norepinephrine bitartrate market. Governments and private entities are investing more in healthcare services, creating a conducive environment for market expansion[3].

Impact of Technological Advancements

Technological advancements in drug delivery systems have significantly improved the administration and efficacy of norepinephrine bitartrate. For instance, sustained-release formulations enhance patient compliance and provide a more stable release of the medication, contributing to market growth[3].

Market Trends

Growing Demand for Critical Care Medications

The increasing need for critical care medications due to rising rates of cardiovascular illnesses and septic shock is a key trend driving the norepinephrine bitartrate market. Norepinephrine's effectiveness in treating these conditions makes it a vital component of critical care regimens[3][4].

Expanding Therapeutic Applications

Research is expanding the therapeutic applications of norepinephrine beyond traditional uses. Emerging studies explore its potential in addressing neurodegenerative diseases and cognitive disorders, which could further broaden the market scope[3].

Conclusion

The norepinephrine bitartrate market is poised for significant growth driven by increasing demand for critical care medications, technological advancements, and expanding therapeutic applications. Despite regulatory and supply chain challenges, the market is expected to continue its upward trajectory, driven by the critical role norepinephrine plays in managing cardiovascular and neurological conditions.

Key Takeaways

• The global norepinephrine bitartrate market is valued at US$ 210 million in 2023 and is expected to reach US$ 301.3 million by 2030.
• The broader norepinephrine market is expected to reach USD 871.6 million by 2028, with a CAGR of 12.2%.
• Key drivers include the increasing prevalence of cardiovascular diseases, an aging population, and technological advancements.
• Regulatory challenges and supply chain disruptions are significant restraints.
• The market is segmented by type, application, and geography.
• Key players include CAMBREX PROFARMACO MILANO SRL, CHEMPACIFIC CORP, and others.

FAQs

What is the forecasted market size of the norepinephrine bitartrate market by 2030?

The norepinephrine bitartrate market is expected to reach US$ 301.3 million by 2030[1].

What is the CAGR of the norepinephrine bitartrate market from 2024 to 2030?

The norepinephrine bitartrate market is expected to exhibit a CAGR of 5.3% from 2024 to 2030[1].

What are the primary applications of norepinephrine bitartrate?

The primary applications include injections and other medical uses, particularly in treating septic shock and hypotension[1][4].

Who are the key players in the norepinephrine bitartrate market?

Key players include CAMBREX PROFARMACO MILANO SRL, CHEMPACIFIC CORP, CURIA NEW YORK INC, and others[1].

How has the COVID-19 pandemic impacted the norepinephrine market?

The COVID-19 pandemic has caused supply chain disruptions, which have hampered market growth. However, the increased need for critical care medications has also driven demand for norepinephrine[3].

Sources

1. Pharmaceutical Grade Norepinephrine Bitartrate Market Report - Valuates Reports
2. Norepinephrine bitartrate - New Drug Approvals
3. Norepinephrine (Noradrenaline) Market Report - Business Research Insights
4. Norepinephrine Drug Market - Market Research Intellect
5. Noradrenaline bitartrate - Tocris Bioscience