CLONAZEPAM - Generic Drug Details

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

Clonazepam is the generic ingredient in three branded drugs marketed by Alembic, Barr, Endo Operations, Sun Pharm Inds Inc, Roche, Accord Hlthcare, Actavis Elizabeth, Aurobindo Pharma Usa, Chartwell Rx, Norvium Bioscience, Prinston Inc, Rubicon, Sandoz, Teva, Watson Labs, and Cheplapharm, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for clonazepam. Thirty-three suppliers are listed for this compound.

Summary for CLONAZEPAM

US Patents:	0
Tradenames:	3
Applicants:	16
NDAs:	18
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	33
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	61
Patent Applications:	6,606
Drug Prices:	Drug price trends for CLONAZEPAM
Drug Sales Revenues:	Drug sales revenues for CLONAZEPAM
What excipients (inactive ingredients) are in CLONAZEPAM?	CLONAZEPAM excipients list
DailyMed Link:	CLONAZEPAM at DailyMed

See drug prices for CLONAZEPAM

See drug sales revenues for CLONAZEPAM

Recent Clinical Trials for CLONAZEPAM

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

Sponsor	Phase
Icahn School of Medicine at Mount Sinai	Phase 4
Federal University of Minas Gerais	Phase 4
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez	N/A

See all CLONAZEPAM clinical trials

Pharmacology for CLONAZEPAM

Drug Class

Benzodiazepine

Medical Subject Heading (MeSH) Categories for CLONAZEPAM

Anticonvulsants

GABA Modulators

Anatomical Therapeutic Chemical (ATC) Classes for CLONAZEPAM

N03AE	Benzodiazepine derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for CLONAZEPAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Usa	CLONAZEPAM	clonazepam	TABLET;ORAL	075150-003	Oct 5, 1998	AB	RX	No	No
Prinston Inc	CLONAZEPAM	clonazepam	TABLET;ORAL	077856-002	Jun 28, 2006	AB	RX	No	No
Endo Operations	CLONAZEPAM	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	077171-002	Aug 3, 2005	AB	RX	No	No
Rubicon	CLONAZEPAM	clonazepam	TABLET;ORAL	075468-001	Oct 6, 2000	AB	RX	No	No
Actavis Elizabeth	CLONAZEPAM	clonazepam	TABLET;ORAL	074869-003	Oct 31, 1996	AB	RX	No	No
Actavis Elizabeth	CLONAZEPAM	clonazepam	TABLET;ORAL	074869-001	Oct 31, 1996	AB	RX	No	No

Expired US Patents for CLONAZEPAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-003	Dec 23, 1997
Cheplapharm	KLONOPIN	clonazepam	TABLET;ORAL	017533-003	Approved Prior to Jan 1, 1982
Cheplapharm	KLONOPIN	clonazepam	TABLET;ORAL	017533-001	Approved Prior to Jan 1, 1982
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-001	Dec 23, 1997
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-004	Dec 23, 1997
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-004	Dec 23, 1997

CLONAZEPAM Market Analysis and Financial Projection Experimental

Clonazepam Market Dynamics and Financial Trajectory

Introduction to Clonazepam

Clonazepam, a benzodiazepine, is widely used for treating anxiety disorders, panic disorders, and certain types of seizures. The market for clonazepam has been experiencing significant growth, driven by various factors.

Market Size and Growth

The clonazepam market has demonstrated robust growth in recent years. As of 2023, the market size was valued at $1.37 billion and is expected to grow to $1.48 billion in 2024, reflecting a compound annual growth rate (CAGR) of 7.9%[1][3][4].

By 2028, the market is projected to reach $2.01 billion, maintaining a CAGR of 8%. This strong growth trajectory is attributed to several key factors.

Market Drivers

Increasing Prevalence of Anxiety and Panic Disorders

The rising incidence of anxiety and panic disorders among both pediatric and adult populations has significantly driven the demand for clonazepam. Heightened awareness about mental health issues and the growing acceptance of benzodiazepines as a treatment option have also contributed to this trend[1][3][4].

Growing Awareness of Mental Health

Increased awareness and reduced stigma around mental health disorders have led to higher diagnosis rates and subsequent prescription rates for clonazepam. This shift in societal attitudes has been a major driver of market growth[1][3][4].

Expanding Geriatric Population

The global population is aging, and older adults are more likely to suffer from conditions such as epilepsy and insomnia, for which clonazepam is often prescribed. This demographic shift is expected to continue driving market growth[1][3][4].

Adoption of Telemedicine

The increasing adoption of telemedicine has improved access to healthcare services, including mental health treatments. This has led to more prescriptions and better adherence to medication regimens, further boosting the clonazepam market[1][3][4].

Market Segmentation

By Type

The clonazepam market is segmented by type into tablets and injections. Tablets are the most common form, but there is also a growing demand for other formulations such as oral disintegrating tablets and oral solutions[1].

By Application

The market is segmented by application into adult and child uses. The adult segment dominates the market due to the higher prevalence of anxiety and panic disorders in this demographic[1].

By End User

The end users of clonazepam include hospitals, homecare settings, and specialty clinics. Hospitals and homecare settings are significant segments due to the need for continuous care and monitoring for patients using clonazepam[1].

Regional Analysis

Largest Market

As of 2023, North America was the largest region in the clonazepam market. This is due to the high prevalence of mental health disorders and well-established healthcare infrastructure in the region[1].

Fastest-Growing Region

Asia-Pacific is expected to be the fastest-growing region in the forecast period. This growth is driven by increasing awareness of mental health, expanding healthcare infrastructure, and a large and growing population[1].

Key Trends

Expansion of Digital Health Solutions

The integration of digital health technologies, including telemedicine and digital therapeutics, is expected to enhance patient access and adherence to clonazepam treatment. This trend is set to continue and drive market growth[1][3][4].

Development of Novel Formulations

Pharmaceutical companies are focusing on developing innovative formulations of clonazepam to improve efficacy and patient compliance. These novel formulations are likely to attract more patients and healthcare providers[1][3][4].

Shift Toward Sustainable and Ethical Sourcing

There is a growing trend toward sustainable and ethical sourcing practices in the pharmaceutical industry. This shift is expected to influence the clonazepam market as companies prioritize environmentally friendly and socially responsible practices[1][3][4].

Advancements in Biosimilar and Biogeneric Production

Advancements in the production of biosimilars and biogenerics are expected to impact the clonazepam market. These alternatives can offer cost-effective options for patients, potentially expanding the market reach[1][3][4].

Market Restraints

Fluctuations in Raw Material Costs

Fluctuations in the cost of raw materials can affect the production costs of clonazepam, potentially restraining market growth. This volatility can make it challenging for manufacturers to maintain stable pricing[5].

Presence of Generic Versions and Alternative Medications

The presence of generic versions of clonazepam and alternative competing medications can reduce the market share of branded products. This competition can limit the growth potential of the market[5].

Market Opportunities

Innovations in Pharmaceutical Manufacturing

Innovations in pharmaceutical manufacturing can enhance the formulation and delivery of clonazepam, making it more effective and user-friendly. These innovations present significant opportunities for market growth[5].

Integration with Digital Health Technologies

The integration of clonazepam with digital health technologies such as telemedicine and digital therapeutics can improve patient access and treatment outcomes. This integration is a key opportunity for expanding the market[5].

Macro Economic Scenario

Impact of High Inflation

High inflation can affect the cost of raw materials and production costs, potentially impacting the profitability of clonazepam manufacturers. However, the essential nature of the drug means demand is less elastic to price changes[1].

Impact of the Ukraine-Russia War

Global conflicts such as the Ukraine-Russia war can disrupt supply chains and affect the availability of raw materials, which could impact the clonazepam market. However, the market's resilience and the critical nature of the drug mitigate these risks to some extent[1].

Impact of COVID-19

The COVID-19 pandemic highlighted the importance of mental health and increased the demand for medications like clonazepam. The pandemic also accelerated the adoption of telemedicine, which has positively impacted the market[1].

Key Takeaways

• The clonazepam market is expected to grow from $1.37 billion in 2023 to $2.01 billion by 2028 at a CAGR of 8%.
• Key drivers include the increasing prevalence of anxiety and panic disorders, growing awareness of mental health, and the expanding geriatric population.
• The market is segmented by type, application, and end user, with North America being the largest region and Asia-Pacific the fastest-growing.
• Trends such as the expansion of digital health solutions, development of novel formulations, and advancements in biosimilar and biogeneric production are expected to shape the market.
• Restraints include fluctuations in raw material costs and the presence of generic versions and alternative medications.

FAQs

What is the current market size of clonazepam and its projected growth?

The clonazepam market size was $1.37 billion in 2023 and is expected to grow to $1.48 billion in 2024. By 2028, it is projected to reach $2.01 billion at a CAGR of 8%[1][3][4].

What are the main drivers of the clonazepam market?

The main drivers include the increasing prevalence of anxiety and panic disorders, growing awareness of mental health, expanding geriatric population, and the rising adoption of telemedicine[1][3][4].

Which region is the largest and fastest-growing in the clonazepam market?

North America is the largest region, while Asia-Pacific is expected to be the fastest-growing region in the forecast period[1].

What are the key trends expected to shape the clonazepam market?

Key trends include the expansion of digital health solutions, development of novel formulations, shift toward sustainable and ethical sourcing, and advancements in biosimilar and biogeneric production[1][3][4].

What are the major restraints affecting the clonazepam market?

Major restraints include fluctuations in the cost of raw materials and the presence of generic versions and alternative competing medications[5].

Sources

1. The Business Research Company, "Clonazepam Global Market Report 2024".
2. OpenPR, "Clonazepam Market Trends, Top Companies, Share, Growth".
3. EINPresswire, "Global Clonazepam Market Set For 8% Growth, Reaching $2.01 Billion By 2028".
4. GII Research, "Clonazepam Global Market Report 2024".
5. ResearchAndMarkets, "Clonazepam Market Size, Competitors & Forecast to 2030".