NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Drug Patent Profile

Which patents cover Norepinephrine Bitartrate In 0.9% Sodium Chloride, and what generic alternatives are available?

Norepinephrine Bitartrate In 0.9% Sodium Chloride is a drug marketed by Inforlife and Long Grove Pharms and is included in two NDAs. There are seven patents protecting this drug.

This drug has three patent family members in two countries.

The generic ingredient in NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE 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 0.9% Sodium Chloride

A generic version of NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE was approved as norepinephrine bitartrate by MEITHEAL on March 3^rd, 2003.

Summary for NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

International Patents:	3
US Patents:	7
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Clinical Trials:	9
DailyMed Link:	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE at DailyMed

Recent Clinical Trials for NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

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 0.9% SODIUM CHLORIDE clinical trials

Pharmacology for NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

Drug Class

Catecholamine

US Patents and Regulatory Information for NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Inforlife	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	215700-001	Sep 15, 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
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 IN 0.9% SODIUM CHLORIDE

See the table below for patents covering NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE around the world.

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

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Market Analysis and Financial Projection Experimental

Norepinephrine Bitartrate in 0.9% Sodium Chloride: Market Dynamics and Financial Trajectory

Introduction

Norepinephrine Bitartrate in 0.9% Sodium Chloride is a critical care medication used to raise blood pressure in adult patients with severe, acute hypotension. This article delves into the market dynamics and financial trajectory of this essential drug, highlighting its indications, market size, growth drivers, and recent developments.

Indications and Clinical Use

Norepinephrine Bitartrate in 0.9% Sodium Chloride is indicated for the treatment of severe, acute hypotension in adult patients. It works as a peripheral vasoconstrictor and an inotropic stimulator of the heart, making it a vital component in critical care settings[1][3].

Market Size and Growth

The global norepinephrine and noradrenaline market, which includes Norepinephrine Bitartrate in 0.9% Sodium Chloride, was valued at USD 0.42 billion in 2023. This market is projected to grow to USD 0.55 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 3.4% during this period[2].

Driving Factors

Several factors are driving the growth of the norepinephrine and noradrenaline market:

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in critical care units, have increased the demand for reliable and effective medications like Norepinephrine Bitartrate in 0.9% Sodium Chloride[2].

Growing Geriatric Population

The increasing geriatric population is another significant driver. Older adults are more prone to acute hypotensive conditions, thereby increasing the need for this medication[2].

Focus on Patient Outcomes

A rising focus on improving patient outcomes has led to a greater emphasis on using high-quality, reliable medications. This has boosted the demand for Norepinephrine Bitartrate in 0.9% Sodium Chloride, especially in its premix formulation which enhances patient safety and operational efficiencies[3].

Market Segmentation

The norepinephrine and noradrenaline market is segmented based on type and application:

Type

• Oral Medication: Though less common for acute hypotension, oral forms are used in certain cases.
• Intravenous Drip: This is the most common form for Norepinephrine Bitartrate in 0.9% Sodium Chloride, given its immediate effect in critical care settings[2].

Application

• Acute Hypotensive Shock: The primary application for Norepinephrine Bitartrate in 0.9% Sodium Chloride.
• Peripheral Vasodilatation Shock: Another critical application where vasoconstriction is necessary.
• Others: Includes various other critical care scenarios where blood pressure management is crucial[2].

Recent Developments

Strategic In-Licensing

Long Grove Pharmaceuticals recently secured the commercial rights to Norepinephrine in 0.9% Sodium Chloride premix formulation from Nevakar Injectables, Inc. This move aims to enhance supply reliability and patient safety by providing a room-temperature stable, ready-to-use formulation in three commonly administered strengths[3].

Regulatory Approvals

Nevakar Injectables, Inc. received FDA clearance for Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection as a 505(b)(2) New Drug Application (NDA) in October 2022. This approval underscores the regulatory support for this critical care medication[3].

Supply Chain and Safety

Voluntary Recalls

Historically, there have been voluntary recalls due to issues such as discoloration, which can indicate degradation and decreased potency of the medication. For instance, PharMEDium Services, LLC recalled several lots of Norepinephrine Bitartrate in 0.9% Sodium Chloride due to such concerns[4].

Enhancing Patient Safety

The introduction of premix formulations has been a significant step in enhancing patient safety by eliminating the risks associated with compounding. As Peter Karas, Chief Commercial Officer of Long Grove Pharmaceuticals, noted, "Norepinephrine Premix has the potential to enhance patient safety as well as our customers' operational efficiencies by eliminating the potential risks and complications associated with compounding."[3]

Financial Trajectory

The financial trajectory of Norepinephrine Bitartrate in 0.9% Sodium Chloride is closely tied to the overall growth of the norepinephrine and noradrenaline market. With a projected CAGR of 3.4%, the market is expected to see steady growth driven by increasing demand and advancements in healthcare.

Revenue Projections

Given the market size projections, the revenue from Norepinephrine Bitartrate in 0.9% Sodium Chloride is expected to contribute significantly to the overall market growth. The transition to premix formulations and the strategic in-licensing agreements are likely to enhance revenue streams by ensuring a more reliable and efficient supply chain[2][3].

Key Takeaways

• Market Growth: The global norepinephrine and noradrenaline market is projected to grow to USD 0.55 billion by 2032.
• Driving Factors: Advancements in healthcare infrastructure, growing geriatric population, and a focus on improving patient outcomes are key drivers.
• Market Segmentation: The market is segmented into oral medication and intravenous drip, with acute hypotensive shock being the primary application.
• Recent Developments: Strategic in-licensing and FDA approvals have enhanced supply reliability and patient safety.
• Financial Trajectory: Steady growth is expected, driven by increasing demand and improved supply chain efficiencies.

FAQs

What is the expected market size of the norepinephrine and noradrenaline market by 2032?

The global norepinephrine and noradrenaline market is expected to reach USD 0.55 billion by 2032[2].

What is the CAGR of the norepinephrine and noradrenaline market?

The market is expected to exhibit a CAGR of 3.4% by 2032[2].

What are the primary applications of Norepinephrine Bitartrate in 0.9% Sodium Chloride?

The primary applications include acute hypotensive shock and peripheral vasodilatation shock[2].

Why is the premix formulation of Norepinephrine Bitartrate in 0.9% Sodium Chloride important?

The premix formulation enhances patient safety and operational efficiencies by eliminating the risks associated with compounding[3].

Have there been any recalls of Norepinephrine Bitartrate in 0.9% Sodium Chloride?

Yes, there have been voluntary recalls due to issues such as discoloration indicating degradation and decreased potency[4].

Sources

1. DailyMed: NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE - DailyMed
2. Business Research Insights: Norepinephrine & Noradrenaline Market Size - Forecast To 2032
3. PR Newswire: Long Grove Pharmaceuticals Secures Commercial Rights to an Essential Critical Care Medication
4. FDA: Pharmedium Issues Voluntary Nationwide Recall of 4mg Norepinephrine Bitartrate (16mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag