Remifentanil hydrochloride - Generic Drug Details

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

Remifentanil hydrochloride is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Hikma, Nivagen Pharms Inc, and Mylan Institutional, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for remifentanil hydrochloride. Four suppliers are listed for this compound.

Summary for remifentanil hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	722
Patent Applications:	492
What excipients (inactive ingredients) are in remifentanil hydrochloride?	remifentanil hydrochloride excipients list
DailyMed Link:	remifentanil hydrochloride at DailyMed

Recent Clinical Trials for remifentanil hydrochloride

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

Sponsor	Phase
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	N/A
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital	N/A
Cedars-Sinai Medical Center	Phase 2

See all remifentanil hydrochloride clinical trials

Pharmacology for remifentanil hydrochloride

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for remifentanil hydrochloride

N01AH	Opioid anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

Paragraph IV (Patent) Challenges for REMIFENTANIL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ULTIVA	for Injection	remifentanil hydrochloride	1 mg/vial, 2 mg/vial and 5 mg/vial	020630	1	2013-12-27

US Patents and Regulatory Information for remifentanil hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	REMIFENTANIL HYDROCHLORIDE	remifentanil hydrochloride	INJECTABLE;INJECTION	210594-001	Oct 13, 2020	AP	RX	No	No
Hikma	REMIFENTANIL HYDROCHLORIDE	remifentanil hydrochloride	INJECTABLE;INJECTION	210594-002	Oct 13, 2020	AP	RX	No	No
Fresenius Kabi Usa	REMIFENTANIL HYDROCHLORIDE	remifentanil hydrochloride	INJECTABLE;INJECTION	206223-001	Jan 16, 2018	AP	RX	No	No
Nivagen Pharms Inc	REMIFENTANIL HYDROCHLORIDE	remifentanil hydrochloride	INJECTABLE;INJECTION	215635-001	Jun 28, 2024	AP	RX	No	No

Expired US Patents for remifentanil hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-002	Jul 12, 1996	5,466,700*PED
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-003	Jul 12, 1996	5,866,591*PED
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-001	Jul 12, 1996	5,019,583*PED
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-003	Jul 12, 1996	5,019,583*PED

Remifentanil hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Remifentanil Hydrochloride

Introduction to Remifentanil Hydrochloride

Remifentanil hydrochloride is a potent, short-acting opioid analgesic primarily used for anesthesia and pain management during surgical procedures. Developed by GlaxoSmithKline, it acts by binding to opioid receptors in the central nervous system, providing rapid onset and offset of effects, which is crucial for precise control over anesthesia depth and rapid recovery after surgery[1][5].

Market Size and Growth Projections

The remifentanil hydrochloride market has been valued at USD 280.09 million in 2023 and is projected to reach USD 337.7 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 2.10% from 2024 to 2032[1].

Another projection indicates that the market size was USD 272.2 million in 2022 and is expected to surpass USD 346.7 million by 2031, expanding at a CAGR of 2.8%[3].

Key Market Drivers

Rising Demand for Surgical Procedures

The increasing number of surgical procedures globally is a significant driver for the remifentanil hydrochloride market. As the prevalence of chronic diseases rises, so does the need for effective pain management solutions during surgeries[1][3].

Advancements in Healthcare Technology

Advancements in drug delivery systems and formulations are further driving the market expansion. The unique pharmacokinetic profile of remifentanil hydrochloride, characterized by rapid onset and offset of action, makes it a preferred choice for clinicians, especially in minimally invasive surgeries and critical care settings[1][4].

Growing Need for Effective Pain Management

The demand for improved pain control solutions continues to escalate, particularly in surgical interventions and postoperative care. Remifentanil hydrochloride offers clinicians the flexibility to tailor anesthesia regimens according to individual patient needs, contributing to more effective pain management strategies[1].

Regional Market Dynamics

North America

North America is expected to dominate the global remifentanil hydrochloride market due to the high prevalence of chronic diseases and well-established healthcare infrastructure in the region. The higher healthcare expenditure in this region also contributes to its significant market share[1][3].

Europe

Europe is anticipated to be a rapidly growing region in the global market, driven by the rising demand for remifentanil hydrochloride in surgical treatments and procedures. The region's advanced healthcare facilities and increasing awareness about pain management are key factors[3].

Emerging Markets

Emerging economies in Asia Pacific, Latin America, and the Middle East are witnessing rapid market growth due to improving healthcare facilities and increasing awareness regarding pain management. These regions are expected to contribute significantly to the market's expansion in the coming years[1].

Market Segmentation

By Type

The market is segmented by type, including 1mg/vial, 2mg/vial, and 5mg/vial. These different formulations cater to various clinical needs and procedures, ensuring flexibility in anesthesia management[3][4].

By Application

Remifentanil hydrochloride is used in various applications such as endotracheal intubation operations, neurosurgery, outpatient surgery, and postoperative analgesia. Its versatility in different surgical settings is a key factor in its market growth[3][4].

By Distribution Channel

The market is segmented by distribution channels, including hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are anticipated to hold a major share of the market as they are primary medical dispensers and providers in hospital settings[3][4].

Financial Analysis

Revenue Projections

The projected revenue growth from USD 280.09 million in 2023 to USD 337.7 million by 2032 indicates a stable and growing financial trajectory for the remifentanil hydrochloride market[1].

Investment and Collaborations

Collaborations and partnerships among pharmaceutical companies and research institutions for product development and clinical trials are contributing to market growth. Continuous efforts to enhance the safety profile and efficacy of remifentanil hydrochloride formulations are anticipated to fuel market growth in the coming years[1].

Challenges and Opportunities

High Cost and Stability Issues

Remifentanil hydrochloride is noted for its high cost and instability in solution, which can limit its use and compounding in advance. However, these challenges also present opportunities for innovation in drug delivery systems and cost reduction strategies[2].

Regulatory Considerations

The nomination of remifentanil hydrochloride for inclusion on the 503B Bulks List by regulatory bodies such as the FDA highlights the ongoing evaluation and potential expansion of its clinical use. This regulatory scrutiny ensures that the drug meets stringent safety and efficacy standards, further solidifying its market position[2].

Key Takeaways

• Growing Market Size: The remifentanil hydrochloride market is projected to grow from USD 280.09 million in 2023 to USD 337.7 million by 2032.
• Regional Dominance: North America and Europe are expected to dominate the market, with emerging economies showing rapid growth.
• Market Drivers: Rising demand for surgical procedures, advancements in healthcare technology, and the need for effective pain management are key drivers.
• Segmentation: The market is segmented by type, application, and distribution channel, with hospital pharmacies holding a significant share.
• Financial Trajectory: The market is expected to grow at a CAGR of 2.10% from 2024 to 2032.

FAQs

What is remifentanil hydrochloride used for?

Remifentanil hydrochloride is primarily used for anesthesia and pain management during surgical procedures due to its rapid onset and offset of effects.

What are the key drivers of the remifentanil hydrochloride market?

The key drivers include the rising number of surgical procedures, advancements in healthcare technology, and the growing need for effective pain management solutions.

Which regions dominate the remifentanil hydrochloride market?

North America and Europe currently dominate the market, with emerging economies in Asia Pacific, Latin America, and the Middle East showing rapid growth.

What are the challenges associated with remifentanil hydrochloride?

The high cost and instability in solution are significant challenges, but they also present opportunities for innovation and cost reduction strategies.

How is the market segmented?

The market is segmented by type (1mg/vial, 2mg/vial, 5mg/vial), application (endotracheal intubation operations, neurosurgery, etc.), and distribution channel (hospital pharmacies, retail pharmacies, online pharmacies).

Sources

1. Remifentanil Hydrochloride Market | Industry Analysis (2024-2032) - Introspectivemarketresearch.com
2. Remifentanil hydrochloride - University of Maryland, Baltimore
3. Global Remifentanil Hydrochloride Market to Surpass USD 346.7 Mn by 2031 - PR Newswire
4. Global Remifentanil Hydrochloride for Injection Market Size, Trends - Market Research Intellect
5. Remifentanil - AdisInsight - Springer