CAPOTEN Drug Patent Profile

When do Capoten patents expire, and when can generic versions of Capoten launch?

Capoten is a drug marketed by Aarxion Anda Hlding and is included in one NDA.

The generic ingredient in CAPOTEN is captopril. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the captopril profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Capoten

A generic version of CAPOTEN was approved as captopril by HIKMA INTL PHARMS on February 13^th, 1996.

Summary for CAPOTEN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	5
DailyMed Link:	CAPOTEN at DailyMed

Recent Clinical Trials for CAPOTEN

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

Sponsor	Phase
GlaxoSmithKline	Phase 1
Children's Cancer Hospital Egypt 57357	Phase 3
University of Nebraska	Phase 4

See all CAPOTEN clinical trials

US Patents and Regulatory Information for CAPOTEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aarxion Anda Hlding	CAPOTEN	captopril	TABLET;ORAL	018343-005	Jan 17, 1985		DISCN	Yes	No
Aarxion Anda Hlding	CAPOTEN	captopril	TABLET;ORAL	018343-004	Jun 13, 1995		DISCN	Yes	No
Aarxion Anda Hlding	CAPOTEN	captopril	TABLET;ORAL	018343-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for CAPOTEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aarxion Anda Hlding	CAPOTEN	captopril	TABLET;ORAL	018343-004	Jun 13, 1995	5,238,924
Aarxion Anda Hlding	CAPOTEN	captopril	TABLET;ORAL	018343-001	Approved Prior to Jan 1, 1982	5,238,924
Aarxion Anda Hlding	CAPOTEN	captopril	TABLET;ORAL	018343-004	Jun 13, 1995	4,215,104

International Patents for CAPOTEN

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

Country	Patent Number	Title	Estimated Expiration
Austria	375919
Spain	477695
Japan	S55162714	TABLET STRUCTURE

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CAPOTEN

Last updated: July 29, 2025

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Introduction

Capoten, the brand name for the drug captopril, represents a pivotal development in cardiovascular medicine. As an angiotensin-converting enzyme (ACE) inhibitor, captopril revolutionized hypertension treatment and played a significant role in managing heart failure, diabetic nephropathy, and post-myocardial infarction complications. This analysis explores the current market dynamics and financial trajectory of captopril, valuable for stakeholders aiming to understand its commercial landscape and growth potential within the broader pharmaceutical ecosystem.

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Historical Context and Therapeutic Significance

Introduced in the early 1980s by Bristol-Myers Squibb, captopril was among the first oral ACE inhibitors approved for clinical use. Its innovation earned a Nobel Prize in Physiology or Medicine in 1998, underscoring its scientific breakthroughs. Its primary indications—hypertension and congestive heart failure—placed it at the forefront of cardiovascular therapy, dramatically altering treatment patterns worldwide.

Key Attributes:

• Generic Availability: Since patent expiration, captopril has become widely generic, significantly impacting its market dynamics.
• Clinical Efficacy: Proven to reduce blood pressure and decrease mortality in heart failure patients.
• Cost-Effectiveness: Its relatively low cost positioned it as a first-line therapy, especially in low- and middle-income countries.

Market Overview and Current Trends

Generic Competition and Market Penetration

Post-patent expiry, the global captopril market is characterized by intense generic competition. Numerous pharmaceutical manufacturers worldwide produce cost-effective formulations, leading to significant price erosion. According to IQVIA data, generic ACE inhibitors collectively dominate the antihypertensive drug segment, with captopril holding an essential but diminishing niche because of newer ACE inhibitors and ARBs (angiotensin II receptor blockers).

Shifts in Treatment Paradigms

While captopril remains a foundational therapy in hypertension, the advent of newer agents like lisinopril, ramipril, and ARBs (e.g., losartan, valsartan) has resulted in a shift toward these alternatives due to tolerability and dosing convenience. Yet, captopril retains relevance in specific settings:

• Resource-Limited Settings: Cost advantages ensure continued use in regions with constrained healthcare budgets.
• Special Populations: Shorter half-life of captopril allows for pulse dosing in certain therapies, though less favored in chronic management.

Regulatory and Patent Environment

The expiration of key patents in the late 1990s and early 2000s led to a proliferation of generic manufacturers, flooding the market with low-cost options. Regulatory challenges involve quality control to ensure bioequivalence, but generally, the regulatory environment supports widespread generic dissemination.

Financial Trajectory Analysis

Revenue Trends

The global captopril market is now primarily driven by volume sales rather than high margins, as generic competition suppresses prices. Its peak revenues were observed during the 1990s and early 2000s, with sectoral shifts leading to a gradual decline in its market share as newer therapies gained prominence.

• According to industry reports, the global antihypertensive drugs market was valued at approximately $21 billion in 2021, with ACE inhibitors constituting a significant segment. Captopril's specific contribution has increasingly dipped as market preferences shift toward longer-acting, more tolerable agents.

Market Forecast (2023-2028)

Projected trends indicate:

• Declining Revenue Share: Market forecasts anticipate a compound annual growth rate (CAGR) of about 2-3% decline in captopril-specific sales over the next five years, primarily due to decreased prescribing.
• Emerging Markets: Demand in low-income regions remains stable, supporting incremental volume sales.
• Off-Label and Specialized Uses: Limited scope for expansion, primarily restricted to specific clinical scenarios.

Cost Dynamics

Manufacturing costs for generic captopril are low, driven by established synthesis pathways and avoided R&D expenses. Despite price competition, profit margins for producers remain modest, emphasizing volume over value.

Market Drivers and Barriers

Drivers

• Cost-Effectiveness: Favorable in healthcare systems emphasizing affordability.
• Established Clinical Profiles: Long-standing safety and efficacy data bolster its continued use.
• Regulatory Approvals: Widespread generic acceptance accelerates market penetration.

Barriers

• Competition from Novel Agents: ACE inhibitors with improved pharmacokinetics and side-effect profiles.
• Therapeutic Preference for ARBs: Shift of patients to ARBs, perceived as better tolerated.
• Limited Innovation: Lack of formulation improvements or new indications limits growth.

Regulatory and Commercial Strategies

Companies competing in the captopril market focus on maintaining cost leadership, ensuring consistent quality, and expanding into emerging markets. Strategic positioning involves:

• Streamlining supply chains to reduce costs.
• Engaging in price negotiations with public health agencies.
• Exploring niche applications or combination therapies.

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Conclusion and Future Outlook

Captopril's market and financial trajectory reflect a mature, commoditized product with declining revenue prospects in established markets dominated by newer, more convenient therapies. Nonetheless, its cost-effectiveness sustains relevance in resource-constrained environments, ensuring a stable, if modest, ongoing market presence.

In future, innovations are unlikely to revive captopril’s market dominance absent significant formulation or indication breakthroughs. Its role will remain primarily within the context of accessible hypertension management, especially in developing countries. Strategic players in global generic markets should focus on cost efficiency and expansion into high-growth regions to capitalize on this enduring, albeit diminished, therapeutic niche.

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Key Takeaways

• Market Maturity: Captopril's patent expiry led to widespread generic competition, eroding its pricing power and market share in developed regions.
• Stable in Emerging Markets: Cost advantages sustain demand in resource-limited healthcare settings.
• Competitive Pressure: The rise of newer ACE inhibitors and ARBs has diminished captopril’s prescribing frequency.
• Revenue Decline: Industry forecasts project a steady decline in revenues, emphasizing the importance of volume-based strategies.
• Strategic Focus: Companies should leverage manufacturing efficiencies, quality assurance, and geographic expansion to maintain profitability.

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FAQs

1. Will captopril regain market share with new indications or formulations?
Current trends suggest limited opportunities for significant expansion. The focus remains on existing indications, with minimal innovation targeting this mature product.

2. How does the emergence of ARBs influence captopril's future?
ARBs, offering fewer side effects and similar efficacy, have largely supplanted captopril in many clinical contexts, further constraining its growth prospects.

3. Are there ongoing efforts to develop modified-release or combination formulations of captopril?
Limited innovation exists due to patent expiry and market saturation; most efforts focus on newer agents.

4. What role does regulatory environment play in captopril’s market stability?
Ever-expanding regulations for generics maintain high standards, supporting continued market access but also increasing compliance costs.

5. Which regions present the greatest growth potential for captopril?
Emerging markets like India and parts of Africa offer sustained demand due to affordability and need for accessible antihypertensive therapies.

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References

1. IQVIA, Global Market Reports on Antihypertensive Drugs, 2022.
2. Nobel Foundation, Recognition for ACE Inhibitors Discovery, 1998.
3. Bristol-Myers Squibb, Historical Product Data, 1990–2000.
4. World Health Organization, Global Cardiovascular Disease Report, 2021.
5. Pharmaceutical Commerce, Market Trends in Generic Drugs, 2022.