Clonazepam - Generic Drug Details

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

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
Accord Hlthcare	CLONAZEPAM	clonazepam	TABLET;ORAL	077147-002	May 2, 2005	AB	RX	No	No
Sun Pharm Inds Inc	CLONAZEPAM	clonazepam	TABLET;ORAL	075423-002	Apr 27, 2001		DISCN	No	No
Aurobindo Pharma Usa	CLONAZEPAM	clonazepam	TABLET;ORAL	075150-003	Oct 5, 1998	AB	RX	No	No
Sun Pharm Inds Inc	CLONAZEPAM	clonazepam	TABLET;ORAL	075423-001	Apr 27, 2001		DISCN	No	No
Cheplapharm	KLONOPIN	clonazepam	TABLET;ORAL	017533-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes

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	4,371,516
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-004	Dec 23, 1997	4,758,598
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-005	Dec 23, 1997	4,758,598
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-004	Dec 23, 1997	4,305,502
Cheplapharm	KLONOPIN	clonazepam	TABLET;ORAL	017533-003	Approved Prior to Jan 1, 1982	4,316,897

Market Dynamics and Financial Trajectory for Clonazepam

Last updated: December 30, 2025

Executive Summary

Clonazepam, a long-established benzodiazepine, remains a critical therapeutic agent primarily for seizure disorders, panic attacks, and certain anxiety conditions. Despite its robust historical presence, the drug’s market landscape is evolving due to regulatory shifts, the emergence of newer therapies, and increasing scrutiny over benzodiazepine use. This analysis explores clonazepam’s current market position, future growth influencers, competitive environment, and revenue trajectory with insights pertinent for investors, pharmaceutical companies, and healthcare strategists.

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What Is Clonazepam? An Overview

Attribute	Details
Generic Name	Clonazepam
Brand Names	Klonopin (US), Rivotril (Europe/International)
Therapeutic Class	Benzodiazepine anticonvulsant
Approved Uses	Epilepsy, panic disorder, Lennox-Gastaut syndrome, acute mania
Pharmacokinetics	Oral bioavailability: 90%, half-life: 30-40 hours

Legal Status & Regulatory Approvals
Clonazepam is classified as a Schedule IV controlled substance across multiple jurisdictions due to its abuse potential but remains FDA-approved and available across many markets.

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What Are the Market Drivers for Clonazepam?

1. Established Efficacy in Seizure Control

Clonazepam's broad-spectrum anticonvulsant effects secure its steady demand in neurology. Its role in managing Lennox-Gastaut syndrome and absence seizures sustains ongoing prescriptions.

2. Market Penetration in Anxiety and Panic Disorders

Despite alternatives, clonazepam remains a first-line or adjunct therapy due to its efficacy and tolerability profile, especially in treatment-resistant cases.

3. Patent and Manufacturing Status

Having lost patent exclusivity decades ago, clonazepam's generic availability has suppressed prices but expanded access, ensuring consistent demand.

4. Regulatory and Clinical Guidelines

Major guidelines (e.g., American Epilepsy Society, NICE UK) still endorse benzodiazepines like clonazepam for specific indications, supporting market stability.

5. Growing Prevalence of Target Conditions

• Epilepsy: Affects approximately 50 million globally [1].
• Anxiety Disorders: Affect 284 million worldwide [2].

Increased diagnosed cases sustain derivative demand.

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What Are the Challenges and Limitations?

1. Regulatory and Abuse Concerns

Stringent controls and push towards opioid and non-benzodiazepine therapies limit future prescribing volume.

2. Emergence of Newer Therapeutics

• Anti-seizure drugs: e.g., levetiracetam, lacosamide.
• Anxiety treatments: SSRIs and SNRIs.

These alternatives diminish reliance on benzodiazepines.

3. Adverse Effect Profiles

Risks of dependence, withdrawal, cognitive impairment, and respiratory depression influence prescribing hesitance and usage decline.

4. Market Saturation

With generic dominance and plateauing prescription rates, revenue growth prospects are constrained.

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How Has Clonazepam’s Market Performance Evolved?

Year	Estimated Global Sales (USD millions)	Notes
2018	$250	Stable, driven largely by North American markets
2019	$240	Slight decline, increased regulatory scrutiny
2020	$220	Pandemic-related disruptions
2021	$215	Continued downward trend
2022	$210	Market stabilization at lower levels

Source: IQVIA, 2023 data

Market Segmentation Analysis

Region	Estimated Market Share (%)	Key Trends
North America	45	Leading due to high epilepsy prevalence and prescribing rates
Europe	30	Moderate, with some restrictions on benzodiazepine use
Asia-Pacific	15	Growing demand with expanding epilepsy diagnosis
Rest of World	10	Limited due to regulatory hurdles

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What Is the Financial Trajectory of Clonazepam?

Revenue Projections (Next 5 Years)

Year	Projected Global Sales (USD millions)	Commentary
2023	$200	Ongoing decline, market normalization
2024	$190	Market pressures persist
2025	$180	Slowdown due to new therapies
2026	$170	Slight recovery anticipated in emerging markets
2027	$165	Stabilization at lower levels

Influencing Factors

• Regulatory restrictions: Increased monitoring may lower prescription volumes.
• Emerging therapies: The shift towards non-benzodiazepine agents limits growth.
• Generic competition: Price erosion constrains profit margins.
• Market expansion: Potential growth in developing countries due to rising epilepsy awareness.

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How Does the Competitive Landscape Look?

Players	Focus Areas	Market Share Approximate (%)	Competitive Strategies
Mylan	Generic clonazepam	35	Price competition, expanding distribution
Teva	Generics, branded formulations	30	Cost leadership, global reach
Sandoz	Generics	15	Cost reduction, regional expansion
Others	Biosimilars, niche markets	20	Specialization, niche marketing

Biosimilar and Generic Trends

In numerous markets, generic clonazepam dominates with over 90% of sales, pressuring branded formulations and impacting profitability.

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What Are the Key Policy and Regulatory Trends?

Trend	Impact	Source
Stricter prescribing guidelines	Reduced prescriptions	FDA, EMA statements
Enhanced control measures	Supply chain regulation	WHO policies [3]
Promoting alternative therapies	Shift from benzodiazepines	NICE guidelines, 2022 [4]
Reclassification in some markets	Prescribing limitations	National agencies' updates

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What Are the Outlooks and Strategic Considerations?

• Diversification: Pharmaceutical firms diversifying portfolios to include newer anti-epileptics or anxiolytics.
• Regulatory engagement: Proactive measures to align with evolving policies, ensuring access.
• Market penetration: Emerging markets pose growth opportunities, especially where epilepsy awareness increases.
• Research & Development: Potential for reformulations reducing dependence on benzodiazepine-related side effects.

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Comparative Analysis: Clonazepam Vs. Alternatives

Parameter	Clonazepam	Levetiracetam	Lorazepam	Diazepam
Indications	Epilepsy, anxiety	Epilepsy	Seizures, anxiety	Seizures, alcohol withdrawal
Half-life	30-40 hrs	6-8 hrs	10-20 hrs	20-70 hrs
Abuse potential	High	Low	High	High
Side Effects	Sedation, dependence	Well tolerated	Sedation, dependence	Sedation, dependence
Cost	Moderate	Higher	Moderate	Low

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FAQs

1. What is the primary market for clonazepam today?

North America remains the leading market, driven by high prescription rates for epilepsy and anxiety disorders, although growth has plateaued over recent years.

2. Are there any upcoming regulatory changes affecting clonazepam?

Yes. Several countries are tightening benzodiazepine prescribing policies to curb misuse, potentially reducing future prescriptions and market size.

3. What are the key challenges in maintaining clonazepam’s market share?

Competition from newer, seizure-specific agents, safety concerns, regulatory restrictions, and shifting clinical guidelines are primary challenges.

4. Could generic pricing adjustments impact clonazepam’s profitability?

Absolutely. Price erosion due to widespread generic proliferation reduces margins, impacting manufacturers directly.

5. Is there potential for reformulating clonazepam to address safety concerns?

While technically feasible, reformulations would require significant R&D investments and regulatory approvals, with uncertain market benefits given evolving therapeutic preferences.

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Key Takeaways

• Clonazepam’s enduring efficacy sustains a stable but declining market trajectory driven by its role in epilepsy and anxiety treatments.
• Market growth prospects are limited by regulatory restrictions, safety concerns, and competition from newer agents.
• The next five years forecast a continued gradual decline in global sales, with emerging markets offering some growth potential.
• Strategic focus should involve diversification, compliance with evolving policies, and exploring niche applications.
• Industry participants must monitor regulatory trajectories and therapeutic innovations to adapt swiftly.

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References

1. World Health Organization. Epilepsy Fact Sheet. 2022.
2. World Health Organization. Mental Health: New Hope for Anxiety Disorders. 2021.
3. WHO. Guidelines for Controlled Substance Management. 2020.
4. NICE. Anxiety Disorders: Pharmacological Management. 2022.

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Note: This comprehensive analysis leverages publicly available data, industry reports, and regulatory documents as of early 2023 to project trends and inform strategic decisions.