Ketamine hydrochloride - Generic Drug Details

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

Ketamine hydrochloride is the generic ingredient in two branded drugs marketed by Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, and Hospira, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for ketamine hydrochloride. Twelve suppliers are listed for this compound.

Summary for ketamine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	1,252
Patent Applications:	4,394
What excipients (inactive ingredients) are in ketamine hydrochloride?	ketamine hydrochloride excipients list
DailyMed Link:	ketamine hydrochloride at DailyMed

Recent Clinical Trials for ketamine hydrochloride

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

Sponsor	Phase
Brian Anderson, MD	Phase 4
Jay Fournier	Phase 1/Phase 2
University Hospital, Basel, Switzerland	Phase 1

See all ketamine hydrochloride clinical trials

Pharmacology for ketamine hydrochloride

Drug Class	General Anesthetic
Physiological Effect	General Anesthesia

Medical Subject Heading (MeSH) Categories for ketamine hydrochloride

Analgesics

Anesthetics, Dissociative

Excitatory Amino Acid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ketamine hydrochloride

N01AX	Other general anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

US Patents and Regulatory Information for ketamine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	INJECTABLE;INJECTION	074549-002	Jun 27, 1996	AP	RX	No	No
Hospira	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	INJECTABLE;INJECTION	074549-001	Jun 27, 1996	AP	RX	No	No
Eugia Pharma	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	INJECTABLE;INJECTION	076092-001	Sep 30, 2008	AP	RX	No	No
Hikma	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	INJECTABLE;INJECTION	074524-002	Mar 22, 1996	AP	RX	No	Yes
Eugia Pharma	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	INJECTABLE;INJECTION	076092-002	Dec 28, 2001	AP	RX	No	No
Endo Operations	KETALAR	ketamine hydrochloride	INJECTABLE;INJECTION	016812-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Fresenius Kabi Usa	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	INJECTABLE;INJECTION	215808-001	Jan 13, 2023	AP	RX	No	No

Ketamine hydrochloride Market Analysis and Financial Projection Experimental

Ketamine Hydrochloride Market Dynamics and Financial Trajectory

Market Overview

The ketamine hydrochloride market is experiencing a significant and rapid growth phase, driven by its increasing acceptance and efficacy in various medical applications. Here’s a detailed look at the market dynamics and financial trajectory of ketamine hydrochloride.

Market Size and Growth Projections

• The ketamine hydrochloride market has reached substantial values and is anticipated to continue its upward trend. As of 2023, the market size was valued at several billion USD, with projections indicating it will reach even higher values by 2031, exhibiting robust growth rates throughout the forecast period[1].
• Specifically, the injectable ketamine market, a key segment of the ketamine hydrochloride market, was valued at $750 million in 2024 and is projected to reach $3.42 billion by 2034, growing at a CAGR of 16.4%[3].

Segmentation and Applications

Types of Ketamine Hydrochloride

• The market is segmented based on types such as esketamine hydrochloride nasal spray and esketamine hydrochloride injection. Each type has its specific applications and market dynamics[1].

Applications

• Ketamine hydrochloride is used in various applications, including pharmacy and hospital settings. It is particularly notable for its use in treating mental health disorders such as treatment-resistant depression (TRD), anxiety, and PTSD[2][3].

Geographical Distribution

• The market is geographically segmented into regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. North America is forecasted to lead the market, particularly driven by the significant prevalence of mental health conditions in the United States[1][3].

Drivers of Growth

Increasing Prevalence of Mental Health Disorders

• The rising prevalence of mental health disorders, such as depression, anxiety, and PTSD, which are often unresponsive to traditional treatments, is a major driver of the ketamine hydrochloride market. Ketamine provides quick relief, making it an ideal choice for patients and medical professionals[2][3].

Technological Advancements and Acceptance

• Technological advancements and the increasing acceptance of ketamine-based therapies by the medical community are significant drivers. The opening of ketamine clinics and specialized treatment facilities globally has made these therapies more accessible and widely adopted[3].

Aging Population and Chronic Diseases

• The growing aging population and the rising incidence of chronic diseases such as diabetes, cardiovascular diseases, and chronic respiratory diseases also drive the market. These conditions often require medical procedures that may involve the use of ketamine hydrochloride[3].

Challenges and Restraints

Regulatory and Safety Concerns

• Despite its efficacy, ketamine hydrochloride faces regulatory and safety concerns. Studies have highlighted the need for further research to determine optimal treatment lengths and to track adverse reactions over longer periods[2].

Side Effects and Adverse Reactions

• The potential for side effects and adverse reactions, such as psychotomimetic outcomes, is a restraint. However, many studies have shown that ketamine is generally well-tolerated, especially when dose titration is employed[2].

Competitive Landscape

• The market includes both established and emerging players. Companies such as Zoetis, Dechra, Ceva Santé Animale, Chanelle Pharma, Boehringer Ingelheim International GmbH, and Covetrus are key players in the veterinary segment, while other companies specialize in human applications[1][5].

Financial Performance and Projections

Injectable Ketamine Market

• The injectable ketamine market is expected to grow significantly, with a projected value of $3.42 billion by 2034. This segment is driven by the demand for ketamine hydrochloride injections, which are effective in treating chronic pain and mental health disorders[3].

Veterinary Ketamine Hydrochloride Market

• The global veterinary ketamine hydrochloride market, though smaller, is also growing. It was estimated at $12.69 million in 2023 and is projected to grow at a CAGR of 2.81% from 2024 to 2030[5].

Regional Insights

North America

• North America leads the market with a significant share, primarily due to the high prevalence of mental health conditions and advanced psychiatric treatment facilities in the United States[3].

Other Regions

• Other regions, such as Europe, Asia-Pacific, and the Middle-East and Africa, also show promising growth. The Middle-East and Africa region is anticipated to register the fastest CAGR in the veterinary ketamine hydrochloride market[3][5].

Key Trends and Opportunities

Expansion of Ketamine Clinics

• The increasing number of ketamine clinics and specialized treatment facilities is a key trend, making ketamine therapies more widely available and adopted[3].

Technological Advancements

• Technological advancements in drug delivery systems and the development of novel methodologies for faster drug approvals are opportunities that will favor market growth[3].

Growing Demand for Minimally Invasive Procedures

• The rising number of minimally invasive surgical and diagnostic procedures, which require general anesthesia drugs like ketamine, is another driving factor[3].

Conclusion

The ketamine hydrochloride market is poised for significant growth driven by its efficacy in treating mental health disorders, chronic pain, and its increasing acceptance in both human and veterinary medicine. Despite challenges, the market's financial trajectory indicates robust growth rates, making it an attractive segment for investors and healthcare providers.

Key Takeaways

• The ketamine hydrochloride market is experiencing rapid growth due to its efficacy in treating mental health disorders and chronic pain.
• The injectable ketamine market is projected to reach $3.42 billion by 2034, growing at a CAGR of 16.4%.
• North America leads the market, driven by the high prevalence of mental health conditions and advanced psychiatric treatment facilities.
• Technological advancements and the expansion of ketamine clinics are key drivers of market growth.
• The veterinary ketamine hydrochloride market is also growing, albeit at a slower rate, driven by its wide applicability in animal anesthesia.

FAQs

How big is the injectable ketamine market in 2024?

The global market for injectable ketamine is estimated at $750 million in 2024[3].

What is the projected growth rate for the injectable ketamine market from 2024 to 2034?

The worldwide demand for injectable ketamine is forecasted to rise at a CAGR of 16.4% from 2024 to 2034[3].

What are the primary applications of ketamine hydrochloride?

Ketamine hydrochloride is primarily used in treating mental health disorders such as treatment-resistant depression, anxiety, and PTSD, as well as in various surgical procedures[2][3].

Which region leads the ketamine hydrochloride market?

North America leads the market, primarily driven by the high prevalence of mental health conditions and advanced psychiatric treatment facilities in the United States[3].

What is the growth rate of the veterinary ketamine hydrochloride market from 2024 to 2030?

The global veterinary ketamine hydrochloride market is projected to grow at a CAGR of 2.81% from 2024 to 2030[5].

Cited Sources:

1. Market Research Intellect, "Ketamine Hydrochloride Market Size, Scope And Forecast Report".
2. Aetna, "Ketamine for the Treatment of Depression and Other Selected ...".
3. Fact.MR, "Injectable Ketamine Market Size, Share and Statistics 2034".
4. ScienceDirect, "IN Esketamine and IV Ketamine: Results of a multi-site observational ...".
5. Grand View Research, "Veterinary Ketamine Hydrochloride Market Analysis Report, 2018".