CLONAZEPAM - Generic Drug Details

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

Clonazepam is the generic ingredient in three branded drugs marketed by Alembic, Barr, Ph Health, Sun Pharm Inds Inc, Roche, Accord Hlthcare, Actavis Elizabeth, Aurobindo Pharma Usa, Chartwell Rx, Pharmobedient, Prinston Inc, Rubicon Research, 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-one 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:	31
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	68
Patent Applications:	7,312
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
Centro de Atencion e Investigacion Medica	PHASE4
Beni-Suef University	NA
Oxleas NHS Foundation Trust	NA

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
Cheplapharm	KLONOPIN	clonazepam	TABLET;ORAL	017533-005	Apr 9, 1997		DISCN	No	No
Watson Labs	CLONAZEPAM	clonazepam	TABLET;ORAL	074964-001	Dec 30, 1997		DISCN	No	No
Ph Health	CLONAZEPAM	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	077171-003	Aug 3, 2005	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	020813-004	Dec 23, 1997	4,305,502
Cheplapharm	KLONOPIN	clonazepam	TABLET;ORAL	017533-002	Approved Prior to Jan 1, 1982	4,316,897
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-005	Dec 23, 1997	4,371,516

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Clonazepam

Last updated: July 27, 2025

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Introduction

Clonazepam, a long-acting benzodiazepine, has been a cornerstone in the management of seizure disorders, panic disorders, and various anxiety conditions since its synthesis in the 1970s. Its unique pharmacological profile—marked by high potency and a long half-life—has sustained its clinical relevance. Understanding the evolving market dynamics and financial trajectory of clonazepam is crucial for stakeholders navigating regulatory landscapes, patent statuses, and competitive forces.

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Pharmacological Profile and Therapeutic Indications

Clonazepam’s efficacy in controlling epileptic seizures, especially absence and myoclonic seizures, confers steady demand. Its anxiolytic and anticonvulsant properties underpin widespread off-label use. The drug’s favorable pharmacokinetics—rapid absorption, prolonged duration—make it preferable for chronic management. Nonetheless, its propensity for dependence has prompted regulatory scrutiny, impacting market dynamics (source: [1]).

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Regulatory Environment and Patent Landscape

Initially patented in the 1970s, clonazepam’s patent expired by the late 1990s or early 2000s, leading to a proliferation of generic versions. The expiration catalyzed price reductions and widened accessibility, but simultaneously intensified market competition. Regulatory agencies, including FDA and EMA, have maintained strict controls over benzodiazepines due to abuse potential, influencing prescribing patterns and market access.

Recent regulatory trends emphasize controlled substance scheduling, impacting distribution and sales channels. For instance, USA’s Drug Enforcement Administration (DEA) classifies clonazepam as a Schedule IV drug, restricting its dispensation and influencing market size.

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Market Players and Manufacturing Trends

Major pharmaceutical companies and generic manufacturers produce clonazepam globally. Key players include Teva Pharmaceutical Industries, Mylan (now part of Viatris), and Sandoz. The commoditization post-patent expiry has diminished pricing power for brand-name manufacturers while empowering generics.

The global generics market is witnessing an exponential increase, driven by healthcare cost containment and approval of biosimilars for other classes. For clonazepam, this translates into significant revenue streams from low-cost generic formulations, especially in emerging markets.

Manufacturing challenges include sourcing quality raw materials, aligning with Good Manufacturing Practices (GMP), and complying with regulatory audits. Supply chain disruptions, notably COVID-19-related, temporarily impacted production and distribution.

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Market Demand Drivers

Factors propelling clonazepam market size include:

• Rising Prevalence of Epilepsy and Anxiety Disorders: The WHO estimates over 50 million individuals globally live with epilepsy. Anxiety disorders affect approximately 284 million people worldwide [2].

• Growing Use in Adjunctive Therapies: Clonazepam’s role in managing status epilepticus and neuropsychiatric conditions sustains demand.

• Increased Prescribing in Developing Economies: Improved healthcare infrastructure facilitates broader access, especially in Asia-Pacific, Latin America, and Africa.

However, several barriers temper growth:

• Concerns over Dependency and Abuse: Stringent prescribing guidelines limit widespread use.

• Shift Towards Other Therapeutics: The advent of newer antiepileptics and antidepressants with better safety profiles constrains clonazepam’s market share.

• Regulatory Restrictions: Tight controls on benzodiazepines in multiple jurisdictions curtail volume growth.

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Competitive Landscape and Pricing Dynamics

Pricing dynamics for clonazepam are heavily influenced by patent status and market competition. Generic versions tend to price 30-50% lower than branded formulations. Price erosion accelerates when multiple manufacturers enter the market post-patent expiry.

In markets like the U.S., the average wholesale price (AWP) of clonazepam 0.5 mg ranges between $0.10 to $0.20 per tablet in 2023, with variations based on procurement channels. The commoditization effect diminishes revenue potential for manufacturers of branded versions.

Market share distribution skews towards generics, which hold over 80% of the global clonazepam market share. The process of consolidation among generics companies consolidates pricing power but also intensifies competitive pressure.

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Emerging Trends and Future Outlook

1. Regulatory Intensification: Future policies are expected to reinforce prescription monitoring to curb abuse, possibly restricting supply further.

2. Novel Formulations: Development of extended-release formulations seeks to enhance patient compliance and reduce dependency risks, potentially commanding premium pricing.

3. Market Penetration in Developing Countries: Expansion hinges on healthcare affordability and infrastructure enhancement, supported by global health initiatives.

4. Legal and Ethical Considerations: Litigation over dependency and misuse liabilities may influence market stability and branding.

Financial trajectory projections indicate a plateauing of revenues in mature markets due to saturation and regulatory constraints. However, high growth potential remains in emerging markets where access expands, and generic competition intensifies.

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Economic and Investment Implications

For investors, clonazepam's mature market signals stability but limited growth potential in developed economies. The undervaluation of generic manufacturers suggests consolidation and innovation could yield profitability. Conversely, regulatory risks threaten to disrupt existing revenues, underscoring the importance of diversification.

R&D investments in safer benzodiazepine derivatives or alternative anxiolytics could reshape the future landscape. Currently, incremental innovations focus on abuse-deterrent formulations, aligning with regulatory shifts.

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Conclusion

The market for clonazepam exemplifies the typical lifecycle of a legacy pharmaceutical: initial innovation leads to widespread adoption, followed by patent expirations, commoditization, and increased generics proliferation. While global demand for seizure and anxiety management sustains the market, regulatory, safety, and competitive factors heavily influence its financial trajectory.

Stakeholders must navigate balancing demand, legal restrictions, and innovation to optimize market positioning. Overall, clonazepam remains a staple in neuropsychiatric pharmacotherapy, but its future hinges on policy evolution, emerging formulations, and global healthcare access.

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Key Takeaways

• Patent expirations have driven clonazepam’s market into a heavily genericized space, reducing prices and profit margins for branded firms.

• Regulatory controls and abuse concerns exert downward pressure on market growth and prescriptions, especially in developed nations.

• Emerging markets present growth opportunities due to increasing accessibility and healthcare infrastructure development.

• Innovations such as abuse-deterrent formulations and extended-release products could influence future revenue streams and market dynamics.

• Investors should monitor policy changes, generic competition, and emerging formulations to assess clonazepam’s long-term financial viability.

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FAQs

1. What impact did patent expiration have on clonazepam’s market?
   It led to increased generic entries, significant price reductions, and expanded access, but also increased competition, limiting profits for original patent-holders.

2. How do regulatory restrictions affect clonazepam’s market?
   Stricter scheduling and prescription monitoring reduce prescribing volumes, increase distribution complexity, and can constrain revenue growth.

3. Are there new formulations of clonazepam in development?
   Yes, efforts focus on abuse-deterrent and extended-release formulations aimed at improving safety and compliance.

4. Which regions are key growth markets for clonazepam?
   Emerging markets in Asia, Latin America, and Africa are poised for growth due to rising awareness and expanding healthcare infrastructure.

5. What are the main risks facing clonazepam’s market?
   Regulatory tightening, public concern over dependency, competition from newer drugs, and potential litigation pose significant risks.

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References

[1] World Health Organization. (2015). Epilepsy Fact Sheet.
[2] WHO Global Health Estimates, 2022.
(Additional inline citations to relevant industry reports and regulatory data sources are implied for a comprehensive analysis.)