ATRACURIUM BESYLATE - Generic Drug Details

What are the generic sources for atracurium besylate and what is the scope of patent protection?

Atracurium besylate is the generic ingredient in four branded drugs marketed by Baxter Hlthcare, Baxter Hlthcare Corp, Eugia Pharma, Hikma, Hospira, Hospira Inc, Meitheal, Norvium Bioscience, Teva Parenteral, Watson Pharms Teva, and Watson Labs Inc, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for atracurium besylate. Three suppliers are listed for this compound.

Summary for ATRACURIUM BESYLATE

US Patents:	0
Tradenames:	4
Applicants:	11
NDAs:	23
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	14
Patent Applications:	1,162
What excipients (inactive ingredients) are in ATRACURIUM BESYLATE?	ATRACURIUM BESYLATE excipients list
DailyMed Link:	ATRACURIUM BESYLATE at DailyMed

Recent Clinical Trials for ATRACURIUM BESYLATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Tanta University	N/A
Theodor Bilharz Research Institute	Phase 4
Cairo University	Phase 4

See all ATRACURIUM BESYLATE clinical trials

Pharmacology for ATRACURIUM BESYLATE

Drug Class	Nondepolarizing Neuromuscular Blocker
Physiological Effect	Neuromuscular Nondepolarizing Blockade

Medical Subject Heading (MeSH) Categories for ATRACURIUM BESYLATE

Neuromuscular Nondepolarizing Agents

Nicotinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ATRACURIUM BESYLATE

M03AC	Other quaternary ammonium compounds
M03A	MUSCLE RELAXANTS, PERIPHERALLY ACTING AGENTS
M03	MUSCLE RELAXANTS
M	Musculo-skeletal system

US Patents and Regulatory Information for ATRACURIUM BESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	ATRACURIUM BESYLATE PRESERVATIVE FREE	atracurium besylate	INJECTABLE;INJECTION	074900-001	Jul 18, 1997	AP	RX	No	Yes
Eugia Pharma	ATRACURIUM BESYLATE PRESERVATIVE FREE	atracurium besylate	INJECTABLE;INJECTION	206010-001	Apr 8, 2015	AP	RX	No	No
Hikma	ATRACURIUM BESYLATE	atracurium besylate	INJECTABLE;INJECTION	074901-001	Jul 18, 1997	AP	RX	No	Yes
Norvium Bioscience	ATRACURIUM BESYLATE PRESERVATIVE FREE	atracurium besylate	INJECTABLE;INJECTION	206001-001	Apr 7, 2017		DISCN	No	No

Expired US Patents for ATRACURIUM BESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hospira	TRACRIUM PRESERVATIVE FREE	atracurium besylate	INJECTABLE;INJECTION	018831-001	Nov 23, 1983	4,179,507

ATRACURIUM BESYLATE Market Analysis and Financial Projection Experimental

Atracurium Besylate Market Dynamics and Financial Trajectory

Introduction to Atracurium Besylate

Atracurium besylate is a neuromuscular-blocking agent used as an adjunct to general anesthesia to facilitate muscle relaxation during surgical procedures. It is crucial for endotracheal intubation and skeletal muscle relaxation, particularly in advanced surgeries that require mechanical ventilation.

Market Size and Growth

The atracurium besylate market has been experiencing significant growth, driven by several key factors. As of 2023, the market was valued at USD 420.0 million and is projected to reach USD 694.9 million by 2033, with a Compound Annual Growth Rate (CAGR) of 5.3% during the forecast period from 2024 to 2033[2].

Key Drivers of Market Growth

Increasing Number of Surgical Procedures

The rise in the number of surgical interventions globally is a major driver of the atracurium besylate market. This increase is attributed to the growing prevalence of chronic diseases that necessitate complex surgeries. As healthcare systems evolve and prioritize patient outcomes, the demand for effective neuromuscular-blocking agents like atracurium besylate is expected to rise[2].

Advancements in Medical Technologies

Advancements in anesthesia practices and medical technologies are also driving the market growth. These advancements have improved the efficacy and safety profile of atracurium besylate, making it a preferred choice in clinical settings[2].

Government Investments and Research

Rapid technological advancements and increased government investments in research and development activities in the field of anesthetics have further boosted the market. These investments have led to quicker and more efficient manufacturing processes for atracurium besylate[1].

Regional Market Dynamics

North America

North America holds a significant share of the atracurium besylate market, with a market share of around 35%. This dominance is due to the presence of a large number of skilled healthcare professionals specializing in respiratory support and airway management, which is crucial for handling atracurium besylate[2].

Europe

Europe also holds a major share in the atracurium besylate market, driven by increased awareness regarding its use in advanced surgeries and a well-networked pharmaceutical supply chain[1].

Asia-Pacific

The Asia-Pacific region is expected to see substantial growth during the forecast period due to the rising number of chronic illness cases, which can be attributed to lifestyle changes. This region presents a significant opportunity for market expansion[1].

Market Segmentation

By Product Type

Atracurium besylate injection dominated the market by type in 2023, due to its widespread clinical adoption, efficacy, and safety profile. Cisatracurium besylate injection, while significant, trails behind atracurium besylate in market dominance[2].

By Units

The 5 ml segment dominated the market by units, reflecting the common dosage used in clinical settings[2].

By End User

Hospitals are the primary end-users, driving the overall growth of the atracurium besylate market. This is due to the high frequency of surgical procedures performed in hospital settings[2].

Challenges and Restraints

Allergic Reactions

One of the significant restraints on the market is the potential for allergic reactions to atracurium besylate, which can cause anaphylactoid or anaphylactic responses in some patients. This factor impeded the growth of the atracurium besylate market[1].

COVID-19 Impact

The COVID-19 pandemic disrupted the supply chain of raw materials required to manufacture atracurium besylate and slowed down drug production, impacting market growth. However, as the pandemic's effects wane, the market is expected to recover and continue its growth trajectory[1].

Regulatory Hurdles

High costs associated with the development and approval of new drugs, along with stringent regulatory approval processes, pose significant challenges for market players. These hurdles can delay the introduction of new products to the market[2].

Recent Developments

• Aurobindo Pharma: Initiated the construction of a new manufacturing facility in India dedicated to atracurium production in March 2024, aiming to increase output and meet growing global demand[2].
• Pfizer: Announced a strategic partnership with Zhejiang Xianju Pharmaceutical in February 2024 to co-develop and distribute atracurium in the Asian market, focusing on expanding access and improving distribution efficiency[2].
• GlaxoSmithKline: Received FDA approval for a new formulation of atracurium in January 2024, which enhances stability and extends shelf life, aiming to improve its use in clinical settings[2].

Competitive Landscape

The atracurium besylate market is competitive, with several major players focusing on strategies such as mergers, acquisitions, and collaborations to develop better forms of injections and penetrate deeper into the market. Key players include Cristalia Produtos Quimicos Farma. Ltd., Auro Medics Pharma LLC, Grindeks AS, Jiangsu Hengrui Medicine Co., Ltd., and others[1][2].

Financial Projections

The financial trajectory of the atracurium besylate market is positive, with a projected growth from USD 420.0 million in 2023 to USD 694.9 million by 2033. This growth is supported by increasing demand, advancements in medical technologies, and strategic investments by market players[2].

Key Takeaways

• Market Growth: The atracurium besylate market is expected to grow at a CAGR of 5.3% from 2024 to 2033.
• Regional Dominance: North America and Europe hold significant shares, with Asia-Pacific expected to grow substantially.
• Product Dominance: Atracurium besylate injection is the dominant product type.
• End User: Hospitals are the primary end-users.
• Challenges: Allergic reactions and regulatory hurdles are key restraints.

FAQs

What is the expected growth rate of the atracurium besylate market?

The atracurium besylate market is expected to grow at a CAGR of 5.3% from 2024 to 2033[2].

Who are the major players in the global atracurium besylate market?

Major players include Cristalia Produtos Quimicos Farma. Ltd., Auro Medics Pharma LLC, Grindeks AS, Jiangsu Hengrui Medicine Co., Ltd., and others[1][2].

What are the primary drivers of the atracurium besylate market?

The primary drivers include the increasing number of surgical procedures, advancements in medical technologies, and government investments in research and development[1][2].

How has COVID-19 impacted the atracurium besylate market?

COVID-19 disrupted the supply chain and slowed down drug production, but the market is expected to recover as the pandemic's effects wane[1].

What are the common dosages of atracurium besylate used in clinical settings?

The 5 ml segment is the most common dosage used in clinical settings[2].

Sources

1. Allied Market Research: Atracurium Besylate Market Overview 2030[1].
2. Market Research Biz: Atracurium Market Size, Share, Growth | CAGR of 5.3%[2].
3. Ken Research: Global Atracurium Besylate Market Report[3].
4. Market Research Pulse: Atracurium Besylate Market Trends, Scope And Outlook[4].
5. DataM Intelligence: Atracurium Market Growth 2024-2029[5].