Esketamine hydrochloride - Generic Drug Details

What are the generic drug sources for esketamine hydrochloride and what is the scope of patent protection?

Esketamine hydrochloride is the generic ingredient in one branded drug marketed by Janssen Pharms and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Esketamine hydrochloride has sixty-one patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for esketamine hydrochloride

International Patents:	61
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	134
Patent Applications:	33
What excipients (inactive ingredients) are in esketamine hydrochloride?	esketamine hydrochloride excipients list
DailyMed Link:	esketamine hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for esketamine hydrochloride

Constraining patent/regulatory exclusivity:

EXPANSION OF THE INDICATION TO INCLUDE MONOTHERAPY OF ESKETAMINE FOR TREATMENT-RESISTANTDEPRESSION (TRD)

Dosage:

SPRAY;NASAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for esketamine hydrochloride

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

Sponsor	Phase
Reinier de Graaf Groep	Phase 3
Stichting ZiektekostenVerzekering Krijgsmacht	Phase 3
Ambulance Amsterdam	Phase 3

See all esketamine hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for esketamine hydrochloride

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

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

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ESKETAMINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SPRAVATO	Nasal Spray	esketamine hydrochloride	28 mg	211243	3	2023-03-06

US Patents and Regulatory Information for esketamine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes

International Patents for esketamine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	2017528483	Ｖａｌ６６Ｍｅｔ（ＳＮＰ ｒｓ６２６５）遺伝子型特異的投薬レジメン及びうつ病の治療のための方法
China	105073096	Pharmaceutical composition of S-ketamine hydrochloride
China	101466364	Intranasal administration of ketamine to treat depression
European Patent Office	2012762	ADMINISTRATION INTRA-NASALE DE KETAMINE POUR TRAITER LA DEPRESSION (INTRANASAL ADMINISTRATION OF KETAMINE TO TREAT DEPRESSION)

Market Dynamics and Financial Trajectory for Esketamine Hydrochloride

Market Overview

Esketamine hydrochloride, an enantiomer of ketamine, has emerged as a significant player in the psychiatric and mental health treatment landscape. This medication is particularly notable for its use in treating treatment-resistant depression (TRD) and other mental health conditions.

Market Size and Forecast

The global esketamine market is experiencing robust growth. As of 2024, the market size was valued at approximately USD 1.54 billion and is projected to reach USD 2.5 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.23%[1].

Another analysis indicates that the market was valued at USD 1.48 billion in 2023 and is expected to grow to USD 2.2 billion by 2030, with a CAGR of about 5.8%[3].

Driving Factors

Several factors are driving the growth of the esketamine market:

• Increased Patient Base: The rising prevalence of TRD and other mental health conditions has created a significant demand for alternative treatments like esketamine[3].
• Improved Awareness: Enhanced awareness of mental health issues and the limitations of standard pharmacological therapies are pushing patients and healthcare providers towards newer options[1].
• Technological Advancements: Developing technologically advanced healthcare infrastructure and ongoing research projects are providing lucrative growth opportunities[1].
• Regulatory Support: Guidelines and support from regulatory bodies are facilitating the integration of esketamine into treatment protocols[2].

Market Segmentation

The esketamine market is segmented based on several criteria:

• Type: The market is bifurcated into oral medications, injections, nasal sprays, and others. Nasal sprays, particularly, are leading the segment due to their ease of administration and effectiveness[1][3].
• Application: The primary application is in the treatment of TRD, with general anesthesia being another significant use[1][3].
• Geography: The market is classified into North America, Europe, Asia Pacific, and the Rest of the World. North America and Europe currently dominate the market, while the Asia Pacific region is expected to grow rapidly due to urbanization and increased investment in healthcare technology[1].

Distribution Channels

The market is sub-segmented into hospitals and clinics, pharmacies, and other distribution channels. Hospitals and clinics are the primary distribution channels due to the need for controlled administration settings[3].

Challenges and Restraints

Despite the growth, the market faces several challenges:

• High Costs: The annual cost of esketamine treatment is estimated to be around $36,500, making it prohibitively expensive for many patients[4].
• Side Effects: Potential side effects such as hypertension, dissociation, and gastrointestinal effects require careful monitoring, limiting access to the drug[4].
• Regulatory Restrictions: Esketamine can only be administered in a hospital setting, and each administration requires a two-hour monitoring period, further restricting its accessibility[4].

Competitive Landscape

Key players in the market include Merck, Medkoo, Endo International, Janssen Pharmaceutica, and Pfizer. These companies are adopting strategies such as mergers and acquisitions, partnerships, and product launches to reinforce their market share[1][3].

Financial Performance and Projections

The financial trajectory of the esketamine market is promising:

• Revenue Growth: The market is expected to grow significantly over the forecast period, driven by increasing demand and expanding applications[1][3].
• Cost-Effectiveness: Despite the high initial costs, studies have shown that esketamine can be a cost-effective treatment option for TRD when considering the cost-per-remitter[4].

Regional Insights

• North America and Europe: These regions currently dominate the market due to a large number of manufacturers and well-established healthcare infrastructure[1].
• Asia Pacific: This region is expected to grow rapidly due to rapid urbanization, industrialization, and increased investment in smart and efficient healthcare technology[1].

Key Developments

• Regulatory Approvals: The US FDA approved SPRAVATO, a nasal spray by Janssen Pharmaceutical, in August 2020, marking a significant milestone in the market[3].
• Research and Development: Ongoing research projects and collaborations with international universities and prominent vendors are driving innovation and growth in the market[1].

Patient and Clinician Perspectives

• Rapid Response: Clinicians have reported rapid response to treatment with esketamine, with some patients achieving remission quickly. However, not all patients benefit equally from the treatment[2].
• Administration Preferences: Patients and clinicians prefer the nasal spray formulation over injections due to its ease of administration and reduced side effects[2].

Future Outlook

The long-term outlook for the esketamine market is positive, driven by increasing demand, technological advancements, and regulatory support. However, addressing the challenges related to cost, accessibility, and side effects will be crucial for sustained growth.

"Esketamine represents a novel approach to treating depression and other mental health conditions, garnering interest from both healthcare providers and patients seeking new treatment options, which is expected to drive demand within the esketamine market."[3]

Key Takeaways

• The global esketamine market is growing rapidly, driven by increasing demand for alternative treatments for TRD.
• The market is segmented by type, application, and geography, with nasal sprays and TRD treatment being key segments.
• High costs, side effects, and regulatory restrictions are significant challenges.
• Key players are adopting various strategies to reinforce their market share.
• The market is expected to continue growing, driven by technological advancements and regulatory support.

FAQs

What is the current market size of the global esketamine market?

The global esketamine market was valued at approximately USD 1.54 billion in 2024[1].

What is the projected growth rate of the esketamine market?

The market is projected to grow at a CAGR of 6.23% from 2024 to 2031[1].

What are the primary applications of esketamine?

The primary applications are in the treatment of treatment-resistant depression (TRD) and as a general anesthetic[1][3].

Which region dominates the global esketamine market?

North America currently dominates the global market, followed by Europe[1].

What are the major challenges facing the esketamine market?

High costs, potential side effects, and regulatory restrictions requiring administration in a controlled setting are major challenges[4].

Cited Sources

1. Verified Market Research - Esketamine Market Size & Forecast
2. PBS - Public Summary Document (PSD) July 2023 PBAC Meeting
3. GlobeNewswire - Latest Esketamine Market Analysis, Consumption Patterns, Trends, Growth Opportunities, Forecast 2023-2030
4. GHU-Paris - Early effects predict trajectories of response to esketamine in treatment-resistant depression

Last updated: 2024-12-16