KLONOPIN RAPIDLY DISINTEGRATING Drug Patent Profile

Which patents cover Klonopin Rapidly Disintegrating, and what generic alternatives are available?

Klonopin Rapidly Disintegrating is a drug marketed by Roche and is included in one NDA.

The generic ingredient in KLONOPIN RAPIDLY DISINTEGRATING is clonazepam. There are ten drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the clonazepam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Klonopin Rapidly Disintegrating

A generic version of KLONOPIN RAPIDLY DISINTEGRATING was approved as clonazepam by TEVA on September 10^th, 1996.

Summary for KLONOPIN RAPIDLY DISINTEGRATING

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	47
Patent Applications:	4,371
DailyMed Link:	KLONOPIN RAPIDLY DISINTEGRATING at DailyMed

US Patents and Regulatory Information for KLONOPIN RAPIDLY DISINTEGRATING

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-001	Dec 23, 1997		DISCN	Yes	No
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-004	Dec 23, 1997		DISCN	Yes	No
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-002	Dec 23, 1997		DISCN	Yes	No
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-003	Dec 23, 1997		DISCN	Yes	No

Expired US Patents for KLONOPIN RAPIDLY DISINTEGRATING

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	4,305,502
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-001	Dec 23, 1997	4,305,502
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-004	Dec 23, 1997	4,371,516
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-004	Dec 23, 1997	4,305,502

International Patents for KLONOPIN RAPIDLY DISINTEGRATING

See the table below for patents covering KLONOPIN RAPIDLY DISINTEGRATING around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	880001206
United Kingdom	1548022
South Korea	840002651
Israel	67266	SOLID SHAPED ARTICLES CARRYING A PREDETERMINED UNIT QUANTITY OF CHEMICAL AND THEIR MANUFACTURE

KLONOPIN RAPIDLY DISINTEGRATING Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Klonopin (Clonazepam) Rapidly Disintegrating Tablets

Introduction to Klonopin (Clonazepam)

Klonopin, known generically as clonazepam, is a benzodiazepine used to treat various medical conditions, including anxiety disorders, panic disorders, and epilepsy. The market for clonazepam, particularly in its rapidly disintegrating tablet form, is experiencing significant growth driven by several key factors.

Historical Market Growth

The clonazepam market has exhibited robust growth in recent years. From 2023 to 2024, the market size is expected to grow from $1.37 billion to $1.48 billion at a compound annual growth rate (CAGR) of 7.9%[1][4].

Projected Market Growth

Looking ahead, the clonazepam market is set to continue its strong growth trajectory. By 2028, the market is projected to reach $2.01 billion at a CAGR of 8%[1][4].

Drivers of Market Growth

Several factors are driving the growth of the clonazepam market:

Increasing Prevalence of Mental Health Disorders

The rising prevalence of anxiety disorders, panic disorders, and other mental health conditions is a significant driver. Heightened awareness about mental health and increased prescription rates are contributing to this growth[1][4].

Growing Geriatric Population

An expanding elderly population is another key factor, as older adults are more likely to suffer from conditions such as epilepsy and insomnia, for which clonazepam is often prescribed[1][4].

Rise of Telemedicine

The increased adoption of telemedicine has made it easier for patients to access medical care and prescriptions, including those for clonazepam. This trend is expected to continue, driving market growth[1][4].

Insomnia and Other Sleep Disorders

The rising incidence of insomnia and other sleep disorders is also contributing to the demand for clonazepam[1][4].

Market Segmentation

The global clonazepam market is segmented based on several criteria:

By Type

• Tablet
• Injection
• Rapidly disintegrating tablets (ODTs) are gaining popularity due to their ease of administration and improved patient adherence[3].

By Application

• Adult
• Child

By End User

• Hospitals
• Homecare Settings
• Specialty Clinics

Innovations and Trends

Digital Health Solutions

The expansion of digital health solutions is expected to play a significant role in the market's future growth. This includes telemedicine platforms and digital tools for patient management and adherence[1][4].

Novel Formulations

The development of novel formulations, such as orally disintegrating tablets, is a key trend. These formulations offer better taste, faster disintegration, and ease of administration, which are crucial for patient compliance[3].

Sustainable and Ethical Sourcing

There is a growing shift towards sustainable and ethical sourcing practices in the pharmaceutical industry, which will impact the clonazepam market as well[1][4].

Biosimilars and Biogenerics

Advancements in the production of biosimilars and biogenerics are also expected to influence the market, offering more affordable and effective treatment options[1][4].

Competitive Landscape

Key players in the clonazepam market are focusing on strategic diversification, including product expansion and the development of active pharmaceutical ingredients (APIs). For instance, Rusan Pharma Private Limited recently received Good Manufacturing Practice (GMP) approval from the US FDA for its API facility, highlighting the industry's commitment to quality and compliance[1].

Regional Insights

The growth of the clonazepam market varies by region, with factors such as increased awareness of mental disorders, higher prescription rates, and the adoption of digital health solutions driving growth in different areas. North America, particularly the United States, is expected to hold a significant share of the market[1][4].

Patient Adherence and Ease of Administration

Orally disintegrating tablets (ODTs) of clonazepam are gaining popularity due to their ease of administration and improved patient adherence. These tablets do not require additional liquid to swallow, making them suitable for use anywhere and at any time, which is particularly beneficial for patients with difficulty swallowing traditional medications[3].

Risks and Challenges

While the market for clonazepam is growing, there are also risks and challenges associated with its use. For example, long-term use of benzodiazepines like clonazepam can lead to dependence and addiction. Studies have also shown that certain trajectories of benzodiazepine use can increase the risk of injurious falls among elderly patients[2].

Key Takeaways

• The clonazepam market is expected to grow to $2.01 billion by 2028 at a CAGR of 8%.
• Key drivers include the increasing prevalence of mental health disorders, growing geriatric population, rise of telemedicine, and higher incidence of insomnia.
• Innovations such as orally disintegrating tablets, digital health solutions, and sustainable sourcing practices are shaping the market.
• Patient adherence and ease of administration are critical factors in the adoption of clonazepam, particularly in its ODT form.

FAQs

What is the projected growth rate of the clonazepam market?

The clonazepam market is expected to grow at a compound annual growth rate (CAGR) of 8% from 2024 to 2028[1][4].

What are the main drivers of the clonazepam market growth?

The main drivers include the increasing prevalence of mental health disorders, growing geriatric population, rise of telemedicine, and higher incidence of insomnia[1][4].

How are orally disintegrating tablets (ODTs) impacting the clonazepam market?

ODTs are gaining popularity due to their ease of administration and improved patient adherence. They offer better taste, faster disintegration, and do not require additional liquid to swallow[3].

What are the risks associated with long-term use of clonazepam?

Long-term use of clonazepam can lead to dependence and addiction. It also increases the risk of injurious falls among elderly patients, especially when used in certain trajectories[2][5].

How are key players in the clonazepam market strategizing for growth?

Key players are focusing on product expansion, development of active pharmaceutical ingredients (APIs), and strategic alliances to increase their market presence and cater to growing global demand[1].

Sources

1. Global Clonazepam Market Set For 8% Growth, Reaching $2.01 Billion By 2028 - EIN Presswire
2. Benzodiazepine Trajectories and Injurious Fall Risk among US Medicare Beneficiaries - MDPI
3. Orally Disintegrating Tablet Market is Projected to Reach US$ 72.68 Billion with a CAGR of 11.5% by 2034 - GlobeNewswire
4. Clonazepam Global Market Report 2024 - GII Research
5. Klonopin Addiction Treatment in California - Golden Gate Recovery