ROCURONIUM BROMIDE - Generic Drug Details

What are the generic sources for rocuronium bromide and what is the scope of patent protection?

Rocuronium bromide is the generic ingredient in two branded drugs marketed by Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Meitheal, Mylan Institutional, Norvium Bioscience, Piramal Critical, Prinston Inc, Sagent Pharms Inc, Sandoz, Shandong, Steriscience, Tamarang, Teva Pharms, West Ward Pharm Corp, and Organon Usa Inc, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for rocuronium bromide. Twenty-three suppliers are listed for this compound.

Summary for ROCURONIUM BROMIDE

US Patents:	0
Tradenames:	2
Applicants:	19
NDAs:	19
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	57
Patent Applications:	868
What excipients (inactive ingredients) are in ROCURONIUM BROMIDE?	ROCURONIUM BROMIDE excipients list
DailyMed Link:	ROCURONIUM BROMIDE at DailyMed

Recent Clinical Trials for ROCURONIUM BROMIDE

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

Sponsor	Phase
Chosun University Hospital	N/A
Assiut University	Phase 2/Phase 3
Yangzhou University	N/A

See all ROCURONIUM BROMIDE clinical trials

Pharmacology for ROCURONIUM BROMIDE

Drug Class	Nondepolarizing Neuromuscular Blocker
Physiological Effect	Neuromuscular Nondepolarizing Blockade

Anatomical Therapeutic Chemical (ATC) Classes for ROCURONIUM BROMIDE

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

US Patents and Regulatory Information for ROCURONIUM BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Institutional	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	079199-002	Nov 26, 2008	AP	RX	No	No
Mylan Institutional	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	079199-001	Nov 26, 2008	AP	RX	No	No
Eugia Pharma	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	206206-002	Apr 12, 2017	AP	RX	No	No
Prinston Inc	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	212668-002	May 26, 2022	AP	RX	No	No
Meitheal	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	213453-002	May 8, 2023	AP	RX	No	No

Expired US Patents for ROCURONIUM BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Inc	ZEMURON	rocuronium bromide	INJECTABLE;INJECTION	020214-001	Mar 17, 1994	4,894,369*PED
Organon Usa Inc	ZEMURON	rocuronium bromide	INJECTABLE;INJECTION	020214-003	Mar 17, 1994	4,894,369*PED
Organon Usa Inc	ZEMURON	rocuronium bromide	INJECTABLE;INJECTION	020214-002	Mar 17, 1994	4,894,369*PED

ROCURONIUM BROMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rocuronium Bromide

Market Overview

The Rocuronium Bromide market is experiencing a period of significant growth, driven by several key factors. Rocuronium bromide, a non-depolarizing neuromuscular blocking agent, is widely used in anesthesia and critical care settings due to its rapid onset of action and intermediate duration of effect[4].

Market Size and Growth

As of 2023, the global Rocuronium Bromide market was valued at approximately USD 1.2 billion. It is projected to grow to around USD 1.8 billion by 2033, reflecting a compound annual growth rate (CAGR) of about 4.5% from 2024 to 2033[4].

Segmental Analysis

The market is segmented based on type (e.g., 5ml, 10ml) and application (e.g., hospitals, clinics), as well as geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The Asia-Pacific region is expected to witness significant growth due to the expanding healthcare sector, increasing investments in healthcare infrastructure, and rising awareness about advanced medical treatments[3][4].

Key Drivers

Several factors are driving the growth of the Rocuronium Bromide market:

Increasing Surgical Procedures

The global increase in surgical procedures, particularly among the aging population and those with chronic diseases, is a major driver. Rocuronium bromide's role in facilitating these procedures by providing rapid and effective muscle relaxation ensures a steady demand[4].

Emergency and Routine Intubation

The drug's rapid onset of action, typically within 60-90 seconds, makes it ideal for emergency intubations and rapid sequence induction (RSI) protocols. This has led to its widespread adoption in emergency and routine intubation procedures[4].

Advancements in Surgical Techniques

Advancements in surgical techniques, including robotic-assisted and minimally invasive surgeries, also boost the demand for Rocuronium Bromide. The drug's intermediate duration of action makes it suitable for a wide range of surgical procedures[4].

COVID-19 Pandemic Impact

The COVID-19 pandemic highlighted the importance of neuromuscular blocking agents in critical care settings, further increasing the demand for Rocuronium Bromide[4].

Geographical Performance

Asia-Pacific Region

The Asia-Pacific region is expected to be a significant growth area due to its large population base, growing prevalence of chronic diseases, and increasing number of surgical procedures. Countries like China and India are major contributors to this growth[3][4].

North America and Europe

These regions also show steady growth, driven by the aging population, advancements in healthcare, and the continued need for effective neuromuscular blocking agents in surgical and critical care settings[3][4].

Financial Projections

• The global Rocuronium Bromide market is forecast to grow from USD 1.2 billion in 2023 to approximately USD 1.8 billion by 2033, with a CAGR of 4.5%[4].
• In China, the market is expected to grow from its current value to a significantly higher value by 2030, driven by local and global players[3].

Market Challenges and Opportunities

Challenges

Despite the positive growth trajectory, the market faces challenges such as regulatory scrutiny, competition from other neuromuscular blocking agents, and the need for continuous research and development to improve efficacy and safety profiles[4].

Opportunities

Emerging markets in the Asia-Pacific and Latin America regions present significant growth opportunities. Companies are likely to focus on strategic collaborations, mergers and acquisitions, and geographic expansion to tap into these markets[4].

Technological Innovations

Technological advancements are leading to improved formulations and delivery systems for Rocuronium Bromide. Ongoing research and development efforts aimed at enhancing the drug's efficacy and safety profiles will further support market growth[4].

Key Players

The market includes key players such as Synnat Pharma, Aspen API, Seqens, Farmhispania Group, Teva, Curia, Gland Chemicals, Xianju Pharmaceutical, Guangdong Jiabo Pharmaceutical, and Fuan Pharmaceutical. These companies play important roles in both global and local markets, particularly in regions like China[3].

Clinical and Regulatory Aspects

Rocuronium Bromide is approved for use in providing skeletal muscle relaxation to facilitate rapid sequence and routine tracheal intubation, as well as during surgery and mechanical ventilation. The drug's dosing regimen includes intravenous bolus and infusion options, and it has undergone extensive clinical trials to establish its efficacy and safety[5].

Future Outlook

The future outlook for the Rocuronium Bromide market is positive, with steady growth anticipated across various regions and applications. The increasing number of surgical procedures, driven by the growing prevalence of chronic diseases and advancements in surgical techniques, will continue to drive the demand for this drug. Emerging markets and ongoing research and development efforts will further support market expansion[4].

"The global Rocuronium Bromide market has been expanding at a compound annual growth rate (CAGR) of approximately 4-5% over the past few years, with projections indicating continued growth in the coming decade." - DataHorizzon Research[4]

Key Takeaways

• The global Rocuronium Bromide market is growing steadily with a CAGR of 4-5%.
• The drug's rapid onset of action makes it ideal for emergency intubations and RSI protocols.
• Increasing surgical volumes, particularly in aging populations, drive market growth.
• Technological innovations and ongoing research and development efforts support market expansion.
• Emerging markets in the Asia-Pacific and Latin America regions present significant growth opportunities.

FAQs

What is Rocuronium Bromide used for?

Rocuronium Bromide is used to provide skeletal muscle relaxation to facilitate rapid sequence and routine tracheal intubation, as well as during surgery and mechanical ventilation[5].

What is the projected growth rate of the Rocuronium Bromide market?

The global Rocuronium Bromide market is projected to grow at a CAGR of approximately 4.5% from 2024 to 2033[4].

Which regions are expected to see significant growth in the Rocuronium Bromide market?

The Asia-Pacific region, particularly countries like China and India, is expected to witness significant growth due to the expanding healthcare sector and increasing number of surgical procedures[3][4].

What are the key drivers of the Rocuronium Bromide market?

Key drivers include the increasing number of surgical procedures, the drug's rapid onset of action, advancements in surgical techniques, and the impact of the COVID-19 pandemic on critical care settings[4].

Who are the key players in the Rocuronium Bromide market?

Key players include Synnat Pharma, Aspen API, Seqens, Farmhispania Group, Teva, Curia, Gland Chemicals, Xianju Pharmaceutical, Guangdong Jiabo Pharmaceutical, and Fuan Pharmaceutical[3].

Sources:

1. Market Research Intellect - Global Rocuronium Bromide Market Size, Scope And Forecast Report[1].
2. Synapse - Rocuronium Bromide - Drug Targets, Indications, Patents[2].
3. QY Research - Global and China Rocuronium Bromide Market Report & Forecast 2024-2030[3].
4. DataHorizzon Research - Rocuronium Bromide Market Size, Growth and Analysis Report - 2033[4].
5. FDA - 20214s030 Rocuronium Bromide[5].