CISATRACURIUM BESYLATE - Generic Drug Details

What are the generic drug sources for cisatracurium besylate and what is the scope of freedom to operate?

Cisatracurium besylate is the generic ingredient in four branded drugs marketed by Accord Hlthcare, Caplin, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Hengrui Pharma, Hikma, Hospira, Meitheal, Piramal, Piramal Critical, Sagent Pharms Inc, Sandoz Inc, Somerset, Zydus Pharms, Somerset Theraps Llc, and Abbvie, and is included in twenty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for cisatracurium besylate. Sixteen suppliers are listed for this compound.

Summary for CISATRACURIUM BESYLATE

US Patents:	0
Tradenames:	4
Applicants:	17
NDAs:	28
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	12
Patent Applications:	1,254
Drug Prices:	Drug price trends for CISATRACURIUM BESYLATE
What excipients (inactive ingredients) are in CISATRACURIUM BESYLATE?	CISATRACURIUM BESYLATE excipients list
DailyMed Link:	CISATRACURIUM BESYLATE at DailyMed

See drug prices for CISATRACURIUM BESYLATE

Recent Clinical Trials for CISATRACURIUM BESYLATE

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

Sponsor	Phase
Second Affiliated Hospital of Nanchang University	Phase 4
Yichang Humanwell Pharmaceutical Co.,Ltd	Phase 4
Second Affiliated Hospital of Nanchang University	N/A

See all CISATRACURIUM BESYLATE clinical trials

Pharmacology for CISATRACURIUM BESYLATE

Drug Class	Nondepolarizing Neuromuscular Blocker
Physiological Effect	Neuromuscular Nondepolarizing Blockade

Anatomical Therapeutic Chemical (ATC) Classes for CISATRACURIUM BESYLATE

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

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

Paragraph IV (Patent) Challenges for CISATRACURIUM BESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NIMBEX PRESERVATIVE FREE	Injection	cisatracurium besylate	2 mg/mL, 10 mL vial	020551	1	2009-08-12
NIMBEX PRESERVATIVE FREE	Injection	cisatracurium besylate	2 mg/mL, 5 mL vial and 10 mg/mL, 20 mL vial	020551	1	2009-08-04

US Patents and Regulatory Information for CISATRACURIUM BESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Meitheal	CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	211669-001	Apr 25, 2019	AP	RX	No	Yes
Meitheal	CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	211668-001	Apr 25, 2019	AP	RX	No	Yes
Eugia Pharma	CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	209144-001	May 8, 2020	AP	RX	No	No
Piramal Critical	CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	215516-002	May 24, 2022	AP	RX	No	No

Expired US Patents for CISATRACURIUM BESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NIMBEX PRESERVATIVE FREE	cisatracurium besylate	INJECTABLE;INJECTION	020551-002	Dec 15, 1995
Abbvie	NIMBEX	cisatracurium besylate	INJECTABLE;INJECTION	020551-001	Dec 15, 1995
Abbvie	NIMBEX PRESERVATIVE FREE	cisatracurium besylate	INJECTABLE;INJECTION	020551-002	Dec 15, 1995
Abbvie	NIMBEX PRESERVATIVE FREE	cisatracurium besylate	INJECTABLE;INJECTION	020551-003	Dec 15, 1995

CISATRACURIUM BESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cisatracurium Besylate

Introduction to Cisatracurium Besylate

Cisatracurium besylate is a nondepolarizing neuromuscular blocking agent widely used in anesthesia to facilitate muscle relaxation during surgical procedures. Its unique pharmacological profile, including organ-independent metabolism, makes it a valuable asset in clinical settings, particularly for patients with critical conditions or renal impairment.

Market Size and Growth

The global market for cisatracurium besylate injection has been experiencing significant growth. As of 2023, the market size was estimated to be approximately USD 400 million. This market is projected to reach USD 600 million by 2032, reflecting a compound annual growth rate (CAGR) of 5.2%[1][5].

Driving Factors

Several factors are driving the growth of the cisatracurium besylate market:

Increasing Surgical Procedures

The rising number of surgical interventions globally, driven by an aging population and the increasing prevalence of chronic diseases, is a key driver. More frequent and complex surgeries necessitate the use of effective neuromuscular-blocking agents like cisatracurium besylate[3].

Advancements in Anesthesia Practices

Advancements in medical technologies and anesthesia practices have enhanced the efficacy and safety of surgical procedures, further increasing the demand for cisatracurium besylate[3].

Healthcare Expenditure

Increasing healthcare expenditure worldwide is another significant factor contributing to the market's growth. As healthcare systems evolve and prioritize patient outcomes, the demand for high-quality neuromuscular-blocking agents is expected to rise[3].

Market Segmentation

The cisatracurium besylate market can be segmented in various ways:

By Type

Cisatracurium besylate injection, although not the dominant type in the broader atracurium market, holds a significant position due to its specific use cases, particularly in patients with critical conditions or renal impairment[3].

By Units

The market is also segmented by the volume of the injection, with common units including 10 ml, 2.5 ml, and 5 ml. The 5 ml segment often dominates due to its widespread use in clinical settings[3].

By End-User

Hospitals are the primary end-users, driving the overall growth of the market. Other end-users include Ambulatory Surgical Centers (ASCs) and clinics[3].

Regional Dominance

The cisatracurium besylate market, like the broader atracurium market, is dominated by North America, which holds a significant market share. This dominance is attributed to advanced healthcare infrastructure, high healthcare expenditure, and a large number of surgical procedures performed in the region[3].

Financial Trajectory

The financial trajectory of the cisatracurium besylate market is promising, with a steady increase in market size over the forecast period. Here are some key financial highlights:

• Current Market Size: Approximately USD 400 million as of 2023[1][5].
• Projected Market Size: Expected to reach USD 600 million by 2032[1][5].
• Compound Annual Growth Rate (CAGR): 5.2% from 2023 to 2032[1][5].

Challenges and Opportunities

While the market is growing, there are several challenges and opportunities to consider:

Challenges

• High Development Costs: The development and approval of new drugs, including neuromuscular-blocking agents, are costly and involve significant regulatory hurdles. These costs can impact the pace at which new products enter the market[3].
• Regulatory Hurdles: Stringent approval processes impose substantial financial burdens on market players, affecting the market's growth[3].

Opportunities

• Increasing Demand: The rising demand for effective neuromuscular-blocking agents due to the increasing number of surgical procedures and advancements in anesthesia practices presents a significant opportunity for market growth[3].
• Specialized Use Cases: Cisatracurium besylate's unique pharmacological profile, particularly its organ-independent metabolism, offers opportunities in specialized clinical applications, such as in patients with renal impairment[2].

Clinical Usage and Dosage

Cisatracurium besylate is administered in various clinical settings, with specific dosage recommendations:

• Initial Dose: The recommended starting weight-based dose is between 0.15 mg/kg and 0.2 mg/kg administered by bolus intravenous injection[2].
• Maintenance Dose: The recommended maintenance bolus dose is 0.03 mg/kg, with adjustments based on clinical criteria and the response to peripheral nerve stimulation[2].
• Continuous Infusion: For extended surgical procedures, cisatracurium besylate may be administered by continuous infusion, with an initial rate of 3 mcg/kg/minute and subsequent reduction to 1 to 2 mcg/kg/minute to maintain continuous neuromuscular blockade[2].

Key Takeaways

• The cisatracurium besylate market is projected to grow from USD 400 million in 2023 to USD 600 million by 2032, with a CAGR of 5.2%.
• The market is driven by increasing surgical procedures, advancements in anesthesia practices, and rising healthcare expenditure.
• North America dominates the market, and hospitals are the primary end-users.
• The drug's unique pharmacological profile, particularly its organ-independent metabolism, makes it a valuable asset in specialized clinical applications.

FAQs

Q: What is the current market size of the cisatracurium besylate injection market? A: The current market size of the cisatracurium besylate injection market is approximately USD 400 million as of 2023[1][5].

Q: What is the projected growth rate of the cisatracurium besylate market? A: The cisatracurium besylate market is projected to grow at a CAGR of 5.2% from 2023 to 2032[1][5].

Q: What are the primary drivers of the cisatracurium besylate market? A: The primary drivers include the increasing number of surgical procedures, advancements in anesthesia practices, and rising healthcare expenditure[3].

Q: Which region dominates the cisatracurium besylate market? A: North America dominates the cisatracurium besylate market, holding a significant market share[3].

Q: What is the recommended initial dose of cisatracurium besylate for adult patients? A: The recommended starting weight-based dose of cisatracurium besylate is between 0.15 mg/kg and 0.2 mg/kg administered by bolus intravenous injection[2].

Sources

1. DataIntelo: Cisatracurium Besylate Injection Market Research Report 2032.
2. Pfizer Medical Information: Cisatracurium Besylate Dosage and Administration.
3. MarketResearch.biz: Atracurium Market Size, Share, Growth | CAGR of 5.3%.
4. MarketResearchIntellect: Global Cisatracurium Besylate Market Size and Forecast.
5. DataIntelo: Global Cisatracurium Besylate Injection Market Research Report 2032.