CAPOZIDE 50/15 Drug Patent Profile

Which patents cover Capozide 50/15, and when can generic versions of Capozide 50/15 launch?

Capozide 50/15 is a drug marketed by Apothecon and is included in one NDA.

The generic ingredient in CAPOZIDE 50/15 is captopril; hydrochlorothiazide. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the captopril; hydrochlorothiazide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Capozide 50/15

A generic version of CAPOZIDE 50/15 was approved as captopril; hydrochlorothiazide by RISING on December 29^th, 1997.

Summary for CAPOZIDE 50/15

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	1
Patent Applications:	451
DailyMed Link:	CAPOZIDE 50/15 at DailyMed

Recent Clinical Trials for CAPOZIDE 50/15

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

Sponsor	Phase
GlaxoSmithKline	Phase 1

See all CAPOZIDE 50/15 clinical trials

US Patents and Regulatory Information for CAPOZIDE 50/15

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apothecon	CAPOZIDE 50/15	captopril; hydrochlorothiazide	TABLET;ORAL	018709-004	Oct 12, 1984		DISCN	Yes	No

Expired US Patents for CAPOZIDE 50/15

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apothecon	CAPOZIDE 50/15	captopril; hydrochlorothiazide	TABLET;ORAL	018709-004	Oct 12, 1984	4,105,776
Apothecon	CAPOZIDE 50/15	captopril; hydrochlorothiazide	TABLET;ORAL	018709-004	Oct 12, 1984	4,217,347

International Patents for CAPOZIDE 50/15

See the table below for patents covering CAPOZIDE 50/15 around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	7606662
Japan	S6043348
Spain	453161
Malaysia	8300240	MEDICAMENS FOR TREATING HYPERTENSION
Denmark	281985
Norway	763819

Market Dynamics and Financial Trajectory for CAPOZIDE 50/15

Last updated: August 6, 2025

Introduction

CAPOZIDE 50/15 (combination of captopril and hydrochlorothiazide) is a widely prescribed antihypertensive agent used to manage high blood pressure and congestive heart failure. Recognized for its efficacy in controlling hypertension, CAPOZIDE has established a significant presence within the cardiology pharmaceutical sector. Understanding its market dynamics and financial trajectory requires an analysis of competitive landscape, regulatory environment, clinical demand, and manufacturing considerations.

Market Overview and Demand Drivers

The global antihypertensive market, projected to reach USD 33 billion by 2027 (according to Fortune Business Insights), underscores the substantial revenue streams available. Given hypertension's status as a leading cardiovascular risk factor—affecting approximately 1.39 billion people worldwide—the demand for combination therapies like CAPOZIDE remains robust.

CAPOZIDE's appeal lies in its dual-action mechanism: captopril, an ACE inhibitor, combined with hydrochlorothiazide, a thiazide diuretic, offers synergistic blood pressure reduction. Its usage benefits patients with resistant hypertension and those requiring combination therapy for optimal control, thereby sustaining its clinical relevance.

Competitive Landscape

The antihypertensive market includes numerous generic and branded competitors—such as enalapril combinations, losartan-based drugs, and other ACE inhibitor or diuretic formulations. The genericization of CAPOZIDE has led to intense price competition, affecting profit margins. Meanwhile, patent expiry considerations are pivotal; although CAPOZIDE’s patent protections have generally lapsed, manufacturers continue to innovate on formulations and delivery systems to preserve market share.

Furthermore, the emergence of novel drug classes, including angiotensin receptor-neprilysin inhibitors (ARNI) and mineralocorticoid receptor antagonists, diversifies treatment options, potentially impacting CAPOZIDE's market penetration.

Regulatory and Patent Landscape

As a combination of well-established classes, CAPOZIDE benefits from extensive regulatory approval history. However, patent protections, if any, are limited or expired—exposing the drug to generic competition. Regulatory hurdles for older formulations remain minimal, but DEVELOPMENTS in drug approval pathways emphasizing biosimilars and fixed-dose combinations could influence future positioning.

Pricing and Reimbursement Dynamics

Price sensitivity among healthcare providers and payers significantly influences sales. Governments and insurance systems increasingly favor cost-effective generic options. Reimbursement policies favor low-cost, proven medications, exerting pressure on the profit margins of patented formulations. However, in emerging markets, higher uptake persists due to limited access to newer agents.

Manufacturing and Supply Chain Factors

Manufacturing economics, including scale and regulatory compliance, directly impact profitability. The widespread production of CAPOZIDE by generic manufacturers benefits from established supply chains. Potential disruptions—such as supply shortages of key raw materials like captopril or hydrochlorothiazide—could affect availability, impacting revenues.

Environmental regulations and quality standards also influence costs. As markets tighten quality controls, compliance costs may rise, affecting net financial outcomes.

Financial Trajectory Analysis

Historically, CAPOZIDE experienced peak revenues during periods of patent protection and high prescribing rates. Post-patent expiry, revenues declined as generics entered the market, intensifying price competition. Nevertheless, stable demand persists due to the drug’s clinical profile and established physician familiarity, providing a resilient baseline.

Forecasting forward, the market trajectory hinges on several factors:

• Market Penetration of Generics: Increased generic adoption continues to pressure pricing.
• Formulation Innovations: New fixed-dose combinations or sustained-release formulations could rejuvenate sales.
• Emerging Markets Expansion: Growing healthcare infrastructure in Asia-Pacific, Latin America, and Africa offers growth avenues.
• Regulatory Initiatives: Streamlined approval pathways for value-added versions could boost revenue if approaches favor innovation.

In sum, while immediate revenue streams may decline due to generic competition, longer-term growth opportunities exist in emerging markets, formulation innovations, and possibly through value-based pricing strategies.

Conclusion

The market for CAPOZIDE 50/15 exemplifies the broader lifecycle of cardiovascular drugs: robust initial demand, eventual genericization, and ongoing opportunities for market differentiation. Its financial trajectory is shaped by competitive pressures, regulatory developments, market expansion, and innovation potential. Stakeholders should focus on optimization of manufacturing, strategic market penetration, and continual innovation to uphold profitability.

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Key Takeaways

• Market Stability: Despite patent expiries, CAPOZIDE maintains a stable market due to its proven efficacy and physician familiarity.
• Pricing Pressure: Generic competition exerts downward pressure on prices, necessitating cost-efficiency measures.
• Emerging Market Opportunities: Rapidly expanding healthcare infrastructure in emerging markets presents significant growth avenues.
• Innovation as a Differentiator: Development of new formulations or combination therapies can rejuvenate sales and extend product lifecycle.
• Regulatory Environment: Favorable regulatory pathways for value-added versions can influence future revenue streams.

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FAQs

Q1: What factors influence the long-term profitability of CAPOZIDE 50/15?
A1: Long-term profitability depends on patent protection status, generic competition, market expansion strategies, formulation innovations, and regulatory environment changes.

Q2: How does genericization impact the financial trajectory of CAPOZIDE?
A2: Generic entry typically reduces sales prices and margins but can increase volume sold, maintaining overall revenue levels while prompting manufacturers to seek differentiating innovations.

Q3: Are there opportunities to extend the lifecycle of CAPOZIDE?
A3: Yes. Formulation improvements, fixed-dose combination innovations, and expansion into emerging markets can extend its market presence.

Q4: What role do regulatory policies play in the future success of CAPOZIDE?
A4: Regulatory policies favoring faster approval of value-added formulations or biosimilars can create new revenue streams, while stringent standards may increase manufacturing costs.

Q5: How does market competition affect the pricing and sales of CAPOZIDE?
A5: Intensified competition from generics compresses prices but can increase overall sales volume; strategic differentiation and market positioning are essential for maintaining profitability.

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References

1. Fortune Business Insights. “Antihypertensive Drugs Market Size, Share & Industry Analysis, 2027.”
2. World Health Organization. “Hypertension,” 2021.
3. U.S. Food and Drug Administration. “Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).”
4. MarketResearch.com. “Global Cardiovascular Drugs Market.”