Clobazam - Generic Drug Details

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

Clobazam is the generic ingredient in three branded drugs marketed by Otter Pharms, Accord Hlthcare, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Bionpharma, Chartwell Molecular, Hetero Labs Ltd Iii, Hikma, Lupin Ltd, Norvium Bioscience, Taro, Teva Pharms Usa, Upsher Smith Labs, Vistapharm, Lundbeck Pharms Llc, Amneal Pharms Co, Anda Repository, Apotex, Breckenridge, Micro Labs, MSN, Piramal, and Zydus Pharms, and is included in thirty-four NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Clobazam has one hundred and sixty-eight patent family members in nineteen countries.

There are ten drug master file entries for clobazam. Twenty-three suppliers are listed for this compound.

Summary for clobazam

International Patents:	168
US Patents:	3
Tradenames:	3
Applicants:	24
NDAs:	34
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	26
Patent Applications:	6,113
Drug Prices:	Drug price trends for clobazam
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for clobazam
What excipients (inactive ingredients) are in clobazam?	clobazam excipients list
DailyMed Link:	clobazam at DailyMed

See drug prices for clobazam

Recent Clinical Trials for clobazam

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

Sponsor	Phase
Dr Cipto Mangunkusumo General Hospital	Phase 4
Wayne State University	Phase 4
Jazz Pharmaceuticals	Phase 3

See all clobazam clinical trials

Pharmacology for clobazam

Drug Class	Benzodiazepine
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers

Anatomical Therapeutic Chemical (ATC) Classes for clobazam

N05BA	Benzodiazepine derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for clobazam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018		RX	Yes	No			Y
Apotex	CLOBAZAM	clobazam	TABLET;ORAL	209853-001	Jun 9, 2020		DISCN	No	No
Taro	CLOBAZAM	clobazam	TABLET;ORAL	209440-002	Oct 22, 2018		DISCN	No	No
Hetero Labs Ltd Iii	CLOBAZAM	clobazam	TABLET;ORAL	209795-001	Oct 22, 2018	AB	RX	No	No

Expired US Patents for clobazam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-003	Nov 1, 2018
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018

International Patents for clobazam

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2020051317
European Patent Office	1463491	FILM MINCE POURVU D'UNE HETEROGENEITE UNIFORME NON AUTOAGGLOMERANTE, SON PROCEDE D'ELABORATION ET SYSTEMES D'ADMINISTRATION DE MEDICAMENTS AINSI PRODUITS (THIN FILM WITH NON-SELF-AGGREGATING UNIFORM HETEROGENEITY, PROCESS FOR THER PRODUCTION AND DRUG DELIVERY SYSTEMS MADE THEREFROM)
Australia	2020200651	SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
Canada	2678066	FILMS A BASE DE POLYMERES ET SYSTEMES DE DELIVRANCE DE MEDICAMENTS FABRIQUES A PARTIR DE CEUX-CI (POLYMER-BASED FILMS AND DRUG DELIVERY SYSTEMS MADE THEREFROM)

Clobazam Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Clobazam

Introduction to Clobazam

Clobazam, a benzodiazepine derivative, was first synthesized in the 1960s with the goal of providing greater efficacy with fewer side effects compared to other benzodiazepines. It has been approved for various indications, including anxiety and as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome (LGS)[5].

Market Size and Forecast

The clobazam market is experiencing moderate growth, driven by several key factors. The market size is estimated to grow significantly from 2024 to 2031, fueled by increasing demand and expanding applications. The North American market, for instance, is projected to grow at a notable CAGR during the forecast period, driven by the high prevalence of epilepsy and advanced healthcare infrastructure[1][4].

Global Market Drivers

Increasing Prevalence of Epilepsy

The rising incidence of epilepsy worldwide is a significant driver for the clobazam market. Approximately 50 million people globally are affected by epilepsy, with a considerable percentage experiencing refractory seizures. Clobazam's effectiveness in managing these seizures, particularly in patients who do not respond to first-line antiepileptic drugs, increases its demand and contributes to market growth[1].

Advancements in Drug Formulations

Regulatory approvals and advancements in drug formulations also play a crucial role. Positive evaluations by health authorities like the FDA and EMA enable broader market access and encourage the introduction of new formulations. The availability of generic versions following patent expirations promotes healthy competition, leading to cost reductions and increased accessibility for patients[1].

Rising Research Activities and Clinical Trials

Ongoing research into clobazam's potential for various neurological disorders further bolsters its market presence. Clinical trials and studies that demonstrate its efficacy in treatment-resistant epilepsy and other conditions help in expanding its therapeutic applications and reinforcing its market position[1].

Global Market Restraints

Regulatory Challenges

The clobazam market faces significant regulatory challenges. Changes in drug approval processes and safety monitoring can impede the introduction of new formulations. Stringent regulations governing controlled substances can restrict access, particularly in jurisdictions with strict drug laws. Compliance with evolving regulatory landscapes requires substantial investment, delaying market entry and impacting profitability[1].

Side Effects and Safety Concerns

Clobazam is associated with side effects such as sedation, dizziness, and potential for dependence, which can be a restraint. These safety concerns necessitate careful monitoring and may limit its adoption in some patient populations[1].

Competitive Landscape

The market for clobazam is highly competitive, with alternatives such as newer anticonvulsants and anxiolytics offering fewer side effects or improved effectiveness. The proliferation of generic medications exacerbates this competition, leading to price erosion and impacting revenue for clobazam manufacturers. Maintaining market share requires continuous investment in marketing, clinical studies, and potential reformulations[1].

Geographical Segmentation

North America

North America, particularly the United States and Canada, represents a significant market segment due to the high prevalence of epilepsy and advanced healthcare infrastructure. Robust pharmaceutical R&D, strong regulatory frameworks, and high healthcare spending contribute to the rising adoption of innovative therapies, including clobazam[1].

Europe

Europe is another prominent segment, driven by increasing prevalence of neurological disorders, a well-established healthcare system, and supportive governmental policies. These factors promote the use of effective therapies like clobazam[1].

Asia-Pacific

The Asia-Pacific region is witnessing rapid growth, driven by rising awareness about epilepsy treatment and increasing investments in healthcare infrastructure. This region is expected to propel the demand for clobazam in the coming years[1].

Latin America and Middle East & Africa

These regions are gradually emerging as key markets, bolstered by improving healthcare access and rising patient awareness. However, they face challenges such as regulatory hurdles and affordability issues, which could impact market growth[1].

Key Players

The clobazam market is dominated by several major players, including:

• Sanofi: Although Sanofi has been divesting its CNS portfolio, including brands of clobazam, to companies like Pharmanovia, it remains a significant player in the market[2].
• Teva Pharmaceutical Industries
• Mylan N.V.
• Indivior PLC
• Sandoz (a Novartis division)
• Hikma Pharmaceuticals
• Aurobindo Pharma
• Amgen Inc.
• Zydus Cadila
• Lupin Pharmaceuticals
• ROSEMONT Pharma
• Amneal
• Merck KGaA
• Breckenridge Pharmaceutical
• Upsher-Smith[1][4].

Financial Trajectory

Revenue Growth

The financial trajectory of the clobazam market is marked by steady revenue growth. The increasing demand driven by the rising prevalence of epilepsy and the expanding use of clobazam in various neurological disorders contribute to this growth. For instance, the North American market is expected to increase significantly over the forecast period, driven by high healthcare spending and robust R&D activities[1][4].

Impact of Generic Versions

The introduction of generic versions of clobazam following patent expirations has led to increased competition and price reductions. While this can erode revenue for branded products, it also makes the drug more accessible to a wider patient population, thereby sustaining overall market growth[1].

Research and Development Investments

Continuous investments in research and development are crucial for maintaining market share. Companies are focusing on clinical trials and studies to expand the therapeutic applications of clobazam, which helps in reinforcing its market position and driving financial growth[1].

Clinical and Therapeutic Applications

FDA Indications

Clobazam is FDA-approved as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome (LGS) in individuals two years or older. It has also shown efficacy in treatment-resistant adult focal epilepsy (TRAFE) and other seizure types[5].

Non-FDA Indications

Beyond FDA-approved indications, clobazam is used in various other neurological disorders, including anxiety and other seizure types. Its efficacy in these areas is supported by clinical studies and practice parameters, further expanding its therapeutic applications[5].

Market Trends and Future Outlook

Growing Demand for Adjunctive Therapies

There is a growing demand for adjunctive therapies in epilepsy treatment, and clobazam's role in this segment is expected to continue. The drug's ability to manage refractory seizures makes it a valuable option for patients who do not respond to first-line treatments[1].

Increasing Focus on Rare and Orphan Diseases

The pharmaceutical industry is increasingly focusing on rare and orphan diseases, and clobazam's use in conditions like LGS aligns with this trend. This focus is likely to drive further research and development, potentially expanding clobazam's market presence[2].

Key Takeaways

• Growing Market Size: The clobazam market is expected to grow significantly from 2024 to 2031.
• Increasing Prevalence of Epilepsy: The rising incidence of epilepsy is a major driver for the market.
• Regulatory and Competitive Challenges: The market faces regulatory hurdles and intense competition from alternative treatments.
• Geographical Growth: North America, Europe, and the Asia-Pacific region are key growth areas.
• Research and Development: Continuous investment in R&D is crucial for market growth and expanding therapeutic applications.

FAQs

What is the primary indication for clobazam?

Clobazam is primarily indicated as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome (LGS) in individuals two years or older[5].

Which regions are key markets for clobazam?

North America, Europe, and the Asia-Pacific region are the key markets for clobazam, driven by high prevalence of epilepsy and advanced healthcare infrastructure[1].

What are the main challenges facing the clobazam market?

The main challenges include regulatory hurdles, side effects and safety concerns, and intense competition from alternative treatments[1].

Who are the major players in the clobazam market?

Major players include Sanofi, Teva Pharmaceutical Industries, Mylan N.V., Indivior PLC, Sandoz, Hikma Pharmaceuticals, and others[1][4].

How does the introduction of generic versions impact the clobazam market?

The introduction of generic versions leads to increased competition, price reductions, and greater accessibility for patients, but can also erode revenue for branded products[1].

Sources

1. Verified Market Research: Clobazam Market Size, Scope, Growth, Trends and Forecast[1].
2. Biospace: Sanofi Sells 11 CNS Assets to Pharmanovia including Frisium and Gardenal[2].
3. Jazz Pharmaceuticals: Jazz Pharmaceuticals Announces Second Quarter 2023 Financial Results and Raises 2023 Full Year Financial Guidance[3].
4. Valuates Reports: Global Clobazam Market Research Report 2024[4].
5. NCBI Bookshelf: Clobazam - StatPearls[5].