CATAPRES Drug Patent Profile

Which patents cover Catapres, and when can generic versions of Catapres launch?

Catapres is a drug marketed by Boehringer Ingelheim and Lavipharm and is included in two NDAs.

The generic ingredient in CATAPRES is clonidine. There are twenty-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the clonidine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Catapres

A generic version of CATAPRES was approved as clonidine by MYLAN TECHNOLOGIES on July 16^th, 2010.

Summary for CATAPRES

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	205
Clinical Trials:	19
Drug Prices:	Drug price information for CATAPRES
Drug Sales Revenues:	Drug sales revenues for CATAPRES
What excipients (inactive ingredients) are in CATAPRES?	CATAPRES excipients list
DailyMed Link:	CATAPRES at DailyMed

See drug prices for CATAPRES

Recent Clinical Trials for CATAPRES

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

Sponsor	Phase
Rigshospitalet, Denmark	Phase 2/Phase 3
Deventer Ziekenhuis	Phase 3
University College, London	Phase 3

See all CATAPRES clinical trials

US Patents and Regulatory Information for CATAPRES

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	CATAPRES	clonidine hydrochloride	TABLET;ORAL	017407-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Lavipharm	CATAPRES-TTS-1	clonidine	SYSTEM;TRANSDERMAL	018891-001	Oct 10, 1984	AB	RX	Yes	No
Boehringer Ingelheim	CATAPRES	clonidine hydrochloride	TABLET;ORAL	017407-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Boehringer Ingelheim	CATAPRES	clonidine hydrochloride	TABLET;ORAL	017407-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Lavipharm	CATAPRES-TTS-3	clonidine	SYSTEM;TRANSDERMAL	018891-003	Oct 10, 1984	AB	RX	Yes	Yes
Lavipharm	CATAPRES-TTS-2	clonidine	SYSTEM;TRANSDERMAL	018891-002	Oct 10, 1984	AB	RX	Yes	No

Expired US Patents for CATAPRES

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	CATAPRES	clonidine hydrochloride	TABLET;ORAL	017407-001	Approved Prior to Jan 1, 1982	3,454,701
Boehringer Ingelheim	CATAPRES	clonidine hydrochloride	TABLET;ORAL	017407-003	Approved Prior to Jan 1, 1982	3,454,701
Boehringer Ingelheim	CATAPRES	clonidine hydrochloride	TABLET;ORAL	017407-002	Approved Prior to Jan 1, 1982	3,454,701

International Patents for CATAPRES

See the table below for patents covering CATAPRES around the world.

Country	Patent Number	Title	Estimated Expiration
Switzerland	451172	Verfahren zur Herstellung neuer substituierter Phenylamino-1,3-diazacyclopentene-(2)
United Kingdom	1016514
Brazil	6463142
Netherlands	6411516
Netherlands	123037
Switzerland	409980	Verfahren zur Herstellung von substituierten 2-Arylamino-1,3-diazacycloalkenen
Netherlands	6800891

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CATAPRES

Last updated: July 29, 2025

Introduction

CATAPRES (clonidine hydrochloride) is a well-established pharmaceutical agent primarily used to treat hypertension, ADHD, opioid withdrawal, and certain neurological conditions. Its long-standing clinical use, diverse indications, and evolving regulatory landscape significantly influence its market dynamics and future financial trajectory. This report analyzes the key factors shaping CATAPRES's market position, competitive environment, regulatory considerations, and revenue prospects.

Market Overview

The global antihypertensive drug market, valued at approximately USD 35 billion in 2022, underpins the demand for medications like CATAPRES [1]. Clonidine’s role extends beyond hypertension; its off-label applications, especially in opioid withdrawal management, expand its market footprint. The drug’s versatile profile and established safety record have cemented its presence in hospital formularies and outpatient settings.

Market Drivers

1. Rising Prevalence of Hypertension and Comorbidities

Hypertension remains a primary driver, with global prevalence projected to exceed 1.3 billion adults by 2025 [2]. Clonidine's efficacy as a centrally acting agent makes it a vital component for resistant hypertension cases. Additionally, the increasing incidence of ADHD, especially in children and adolescents, sustains demand for clonidine-based therapies.

2. Expansion of Therapeutic Indications

Off-label and adjunct uses, such as for opioid withdrawal (notably during the opioid crisis), bolster its utilization. Public health initiatives to address opioid dependence in North America continue to support clonidine's demand [3].

3. Generic Market Penetration

Post-patent expiration, generic versions have significantly increased accessibility and reduced costs, enabling broader adoption. The generic market dominates the anti-hypertensive segment, contributing to stable revenue streams.

Market Challenges

1. Patent Limitations and Competition

Although the original patent for clonidine expired decades ago, recent formulations or delivery methods may enjoy market exclusivities. Nonetheless, intense competition from generic manufacturers compresses pricing and margins.

2. Alternative Therapeutics

Emerging pharmacological agents—such as beta-blockers, ACE inhibitors, ARBs, and newer centrally acting agents—offer alternative options, reducing clonidine's market share in some indications.

3. Safety and Side Effect Profile

Clonidine's adverse effects, including dry mouth, sedation, rebound hypertension upon abrupt discontinuation, influence prescribing patterns. Newer agents with improved side effect profiles may supplant clonidine in certain uses.

Regulatory and Patent Landscape

1. Patent Status and Market Exclusivity

Existing patents on formulations or delivery mechanisms might restrict entry of new competitors. However, no recent patent extensions have notably protected clonidine from generics. This accelerates erosion of revenue in mature markets.

2. Regulatory Approvals and Labeling

The trajectory of regulatory approvals for new formulations or indications could impact the drug’s marketability. The U.S. Food and Drug Administration (FDA) and other agencies continue to approve branded and generic clonidine medications, maintaining its presence in therapeutic regimens [4].

Financial Trajectory and Revenue Projections

Historically, clonidine has provided stable revenues for pharmaceutical companies due to its established clinical utility and widespread use. Financial data indicates:

• Steady Decline in Brand-Name Sales: Since patent expiry, sales of branded products, such as CATAPRES, have fluctuated minimally, primarily supported by brand loyalty and formulary preferences.

• Growth in Generic Market Share: Generic clonidine accounts for over 85% of total prescriptions, leading to substantially lower average selling prices but enabling volume-driven revenue.

• Potential Impact of New Formulations: Extended-release formulations or transdermal patches could command higher prices, revitalizing revenue streams, although these are relatively niche compared to the main oral formulation.

• Regional Variability: Advanced economies exhibit more aggressive generic substitution, whereas emerging markets may still rely on branded options, maintaining revenue opportunities.

Emerging Trends and Opportunities

1. Novel Delivery Systems

Development of transdermal patches or implantables may improve patient compliance and therapeutic outcomes. While currently limited, such innovations might open premium segments influencing revenue.

2. Focus on Digital and Precision Medicine

Integration with digital health tools to monitor blood pressure and adherence could enhance product value, creating new revenue streams through services and data-driven insights.

3. Market Expansion in Developing Countries

Growing healthcare infrastructure in Asia, Africa, and Latin America presents opportunities for expanding clonidine’s footprint via affordable generics and government health programs.

Risk Factors

• Regulatory Scrutiny: Increased regulation around off-label use and adverse event monitoring could impact sales.

• Market Saturation: The mature nature of clonidine’s market constrains potential growth, emphasizing the importance of related product development.

• Pricing Pressures: Continued cost-containment policies in healthcare systems threaten margins, particularly in markets dominated by generics.

Conclusion

The market dynamics for CATAPRES are characterized by a mature, stable base influenced heavily by generic competition and evolving therapeutic preferences. Its financial trajectory is expected to remain relatively flat or mildly declining without significant innovation or expansion into new indications. However, targeted formulations, regional expansions, and digital integration could provide incremental growth avenues. Overall, CATAPRES’s future market position hinges on strategic innovations and navigating regulatory and competitive landscapes.

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Key Takeaways

• Stable Revenue Base: CATAPRES’s long history and broad clinical utility have established a consistent revenue stream, particularly in generics.

• Competitive Pressure: Patent expirations and high generic market penetration limit pricing power, emphasizing volume over premium pricing.

• Innovation Opportunities: Extended-release formulations and digital health integrations offer potential growth pathways.

• Regional Expansion: Emerging markets present significant opportunities for market share expansion through affordable generics.

• Regulatory environment: Vigilant monitoring of regulatory changes and safety profiles is crucial to sustain market presence.

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FAQs

1. What are the primary therapeutic indications of CATAPRES?
CATAPRES (clonidine) is primarily used to treat hypertension, ADHD, and opioid withdrawal symptoms, with off-label uses in neurological conditions.

2. How does patent expiration affect CATAPRES’s market?
The expiration of patents for clonidine has led to increased generic competition, causing significant price reductions and stable, volume-driven revenues for manufacturers.

3. Are there recent innovations related to CATAPRES formulations?
Yes. Development of transdermal patches and long-acting formulations aim to improve adherence and therapeutic outcomes, potentially creating new market segments.

4. What are the biggest challenges facing CATAPRES’s market growth?
Challenges include competition from newer drugs, safety concerns, side effect profiles, and price pressures from widespread generic adoption.

5. What regions offer the most growth potential for CATAPRES?
Emerging markets in Asia, Africa, and Latin America present significant opportunities for growth through affordable generics and expanding healthcare coverage.

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Sources

[1] MarketWatch, "Global Antihypertensive Drugs Market," 2022.
[2] WHO, "Hypertension Fact Sheet," 2022.
[3] Substance Abuse and Mental Health Services Administration, "Opioid Overdose Prevention," 2022.
[4] FDA, "Clonidine Drug Approvals and Labeling," 2023.