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Last Updated: December 22, 2024

CISATRACURIUM BESYLATE PRESERVATIVE FREE Drug Patent Profile


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Which patents cover Cisatracurium Besylate Preservative Free, and what generic alternatives are available?

Cisatracurium Besylate Preservative Free is a drug marketed by Accord Hlthcare, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Hengrui Pharma, Sandoz Inc, and Somerset Theraps Llc. and is included in seven NDAs.

The generic ingredient in CISATRACURIUM BESYLATE PRESERVATIVE FREE is cisatracurium besylate. There are nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the cisatracurium besylate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cisatracurium Besylate Preservative Free

A generic version of CISATRACURIUM BESYLATE PRESERVATIVE FREE was approved as cisatracurium besylate by SANDOZ INC on February 3rd, 2012.

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Summary for CISATRACURIUM BESYLATE PRESERVATIVE FREE
Drug patent expirations by year for CISATRACURIUM BESYLATE PRESERVATIVE FREE
Pharmacology for CISATRACURIUM BESYLATE PRESERVATIVE FREE

US Patents and Regulatory Information for CISATRACURIUM BESYLATE PRESERVATIVE FREE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare CISATRACURIUM BESYLATE PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 205872-001 Jun 16, 2017 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hainan Poly CISATRACURIUM BESYLATE PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 216539-002 Aug 27, 2024 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fresenius Kabi Usa CISATRACURIUM BESYLATE PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 203182-001 Feb 26, 2015 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Somerset Theraps Llc CISATRACURIUM BESYLATE PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 206791-001 Feb 20, 2019 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

CISATRACURIUM BESYLATE PRESERVATIVE FREE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cisatracurium Besylate Preservative Free

Market Overview

The market for cisatracurium besylate, a non-depolarizing skeletal neuromuscular blocking agent, is part of the broader atracurium market. This segment is driven by several key factors that influence its growth and financial trajectory.

Market Size and Growth

As of 2023, the atracurium market, which includes cisatracurium besylate, was valued at USD 420.0 million. It 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[1].

Key Drivers

Increasing Surgical Procedures

The rise in the number of surgical interventions globally is a significant driver for the cisatracurium besylate market. As surgical procedures increase, so does the demand for effective neuromuscular-blocking agents to facilitate muscle relaxation during anesthesia[1].

Advancements in Anesthesia Practices

Advancements in anesthesia practices and the adoption of newer, more effective neuromuscular-blocking agents like cisatracurium besylate contribute to market growth. These advancements improve patient outcomes and enhance the efficiency of surgical procedures[1].

Rising Prevalence of Chronic Diseases

The increasing prevalence of chronic diseases that necessitate complex surgeries also drives the demand for cisatracurium besylate. This includes surgeries for conditions such as cardiovascular diseases, cancer, and neurological disorders[1].

Market Segmentation

By Type

  • Atracurium Besylate Injection: This segment dominates the market due to its widespread clinical adoption, efficacy, and safety profile.
  • Cisatracurium Besylate Injection: While it trails atracurium besylate in market share, cisatracurium besylate is significant in specific use cases, particularly in patients with critical conditions or renal impairment due to its organ-independent metabolism[1].

By Units

  • The market is segmented by units such as 5 ml, 2.5 ml, and 10 ml, with the 5 ml segment dominating the market[1].

By End-user

  • Hospitals: Hospitals are the primary end-users, driving the majority of the demand for cisatracurium besylate.
  • ASCs (Ambulatory Surgical Centers) and Clinics: These also contribute to the market, although to a lesser extent compared to hospitals[1].

Regional Analysis

North America

North America dominates the atracurium market, including cisatracurium besylate, with a significant market share of around 35%. This is due to advanced healthcare infrastructure, high surgical volumes, and strong market presence of key pharmaceutical companies[1].

Other Regions

Other regions such as Europe, Asia-Pacific, Latin America, and the Middle East & Africa also contribute to the market, with varying growth rates and market shares.

Competitive Landscape

The market for cisatracurium besylate is competitive, with several key players including:

  • GlaxoSmithKline
  • Pfizer
  • Aurobindo Pharma Limited

These companies play a crucial role in driving innovation, ensuring supply chain efficiency, and maintaining market competitiveness[1].

Product Characteristics

Clinical Use

Cisatracurium besylate is used as an adjunct to general anesthesia to facilitate non-emergency endotracheal intubation and to provide muscle relaxation during surgical procedures. It has an intermediate onset and duration of action, making it suitable for a wide range of surgical scenarios[2][4].

Dosage and Administration

Cisatracurium besylate is available in various vial sizes, including 5 ml, 10 ml, and 20 ml, with concentrations of 2 mg/mL and 10 mg/mL. The dosage is typically administered intravenously, and the drug does not affect consciousness, pain threshold, thinking, or memory[2][4].

Safety Profile

Cisatracurium besylate has a favorable safety profile, with no clinically significant effects on heart rate and no triggering of malignant hyperthermia in susceptible patients. However, it must be used cautiously in patients with acid-base and/or serum electrolyte abnormalities and those undergoing hypothermia[4].

Financial Trajectory

Revenue Forecast

The atracurium market, which includes cisatracurium besylate, is expected to grow from USD 420.0 million in 2023 to USD 694.9 million by 2033. This growth is driven by increasing demand, advancements in medical practices, and the expanding need for effective neuromuscular-blocking agents[1].

Market Opportunities

The market will thrive by addressing increased consumer demand and the need for sustainability. Pharmaceutical companies are expected to focus on improving supply chain efficiency, reducing costs, and enhancing the sustainability of their products to meet growing market demands[1].

Challenges and Restraints

Regulatory Scrutiny

Cisatracurium besylate, like other pharmaceutical products, is subject to stringent regulatory scrutiny. Ensuring compliance with regulatory standards and maintaining product quality are crucial for market success[4].

Competition

The market is highly competitive, with multiple players offering similar products. Differentiating products through innovation, pricing strategies, and strong distribution networks is essential to maintain market share[1].

Key Takeaways

  • Market Growth: The atracurium market, including cisatracurium besylate, is expected to grow at a CAGR of 5.3% from 2024 to 2033.
  • Dominant Segment: Atracurium besylate injection dominates the market by type, while the 5 ml segment leads by units.
  • End-user: Hospitals are the primary end-users, driving the majority of the demand.
  • Regional Dominance: North America holds a significant market share.
  • Competitive Landscape: Key players include GlaxoSmithKline, Pfizer, and Aurobindo Pharma Limited.

FAQs

What is the expected market size of the atracurium market by 2033?

The atracurium market is expected to reach USD 694.9 million by 2033[1].

What are the primary drivers of the cisatracurium besylate market?

The primary drivers include the increasing number of surgical interventions, advancements in anesthesia practices, and the rising prevalence of chronic diseases[1].

Which segment dominates the atracurium market by type?

Atracurium besylate injection dominates the market by type[1].

What is the typical dosage and administration of cisatracurium besylate?

Cisatracurium besylate is administered intravenously, available in various vial sizes with concentrations of 2 mg/mL and 10 mg/mL[2][4].

What are the key regions contributing to the atracurium market?

North America dominates the market, followed by Europe, Asia-Pacific, Latin America, and the Middle East & Africa[1].

Sources

  1. MarketResearch.biz: Atracurium Market Size, Share, Growth | CAGR of 5.3% - Report Overview.
  2. FDA: Nimbex (cisatracurium besylate) injection label.
  3. Science.gov: Fixed-dose combinations (FDCs): Topics by Science.gov.
  4. Health Canada: Pr CISATRACURIUM BESYLATE INJECTION (preservative-free) - Consumer Information.

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