CAPTOPRIL; HYDROCHLOROTHIAZIDE - Generic Drug Details

What are the generic sources for captopril; hydrochlorothiazide and what is the scope of freedom to operate?

Captopril; hydrochlorothiazide is the generic ingredient in five branded drugs marketed by Apothecon, Cosette, Ivax Sub Teva Pharms, Rising, Strides Pharma Intl, and Watson Labs, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for CAPTOPRIL; HYDROCHLOROTHIAZIDE

US Patents:	0
Tradenames:	5
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
DailyMed Link:	CAPTOPRIL; HYDROCHLOROTHIAZIDE at DailyMed

Recent Clinical Trials for CAPTOPRIL; HYDROCHLOROTHIAZIDE

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

Sponsor	Phase
GlaxoSmithKline	Phase 1
West China Hospital	Phase 4
Vanderbilt University	Phase 1

See all CAPTOPRIL; HYDROCHLOROTHIAZIDE clinical trials

Pharmacology for CAPTOPRIL; HYDROCHLOROTHIAZIDE

Drug Class	Angiotensin Converting Enzyme Inhibitor Thiazide Diuretic
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for CAPTOPRIL; HYDROCHLOROTHIAZIDE

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

US Patents and Regulatory Information for CAPTOPRIL; HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	captopril; hydrochlorothiazide	TABLET;ORAL	074827-002	Dec 29, 1997		DISCN	No	No
Apothecon	CAPOZIDE 25/25	captopril; hydrochlorothiazide	TABLET;ORAL	018709-002	Oct 12, 1984		DISCN	Yes	No
Ivax Sub Teva Pharms	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	captopril; hydrochlorothiazide	TABLET;ORAL	075055-001	Jun 18, 1998		DISCN	No	No

Expired US Patents for CAPTOPRIL; HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apothecon	CAPOZIDE 50/25	captopril; hydrochlorothiazide	TABLET;ORAL	018709-003	Oct 12, 1984
Apothecon	CAPOZIDE 25/15	captopril; hydrochlorothiazide	TABLET;ORAL	018709-001	Oct 12, 1984
Apothecon	CAPOZIDE 50/25	captopril; hydrochlorothiazide	TABLET;ORAL	018709-003	Oct 12, 1984

Market Dynamics and Financial Trajectory for Captopril and Hydrochlorothiazide

Last updated: July 28, 2025

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Introduction

Captopril and hydrochlorothiazide represent cornerstone medications in the treatment of hypertension and related cardiovascular conditions. As the pharmaceutical landscape evolves, understanding the market dynamics and financial trajectory of these two drugs offers critical insights into their current positioning, growth prospects, and the implications for stakeholders ranging from manufacturers to healthcare providers.

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Historical Context and Regulatory Landscape

Captopril, an angiotensin-converting enzyme (ACE) inhibitor, was among the first oral medications introduced for hypertension management following its approval in the early 1980s. Widely heralded for its efficacy in reducing blood pressure and cardiovascular morbidity, it quickly gained widespread adoption.

Hydrochlorothiazide, a thiazide diuretic, debuted in the 1950s. Its affordability, efficacy, and favorable safety profile cemented its status as a first-line antihypertensive agent. Both drugs benefited from significant patent protection in their initial phases, enabling exclusive market control until patent expirations ushered in generic competition.

The regulatory environment has become increasingly complex, with agencies like the FDA and EMA emphasizing drug safety, quality, and direct competition. Patent cliffs for both drugs—particularly hydrochlorothiazide—have catalyzed a surge in generics, dramatically altering market dynamics.

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Market Size and Current Market Share

The global antihypertensive drugs market, estimated to reach approximately USD 18 billion by 2025 [1], heavily features both captopril and hydrochlorothiazide as foundational agents.

Captopril has seen declining revenues in recent years due to the advent of newer ACE inhibitors (e.g., enalapril, lisinopril) offering improved pharmacokinetic profiles and fewer adverse effects. Nonetheless, it maintains a significant segment, particularly in developing markets and in fixed-dose combinations.

Hydrochlorothiazide remains the most prescribed diuretic globally, accounting for an estimated 65% of diuretic prescriptions in the United States. Despite being a generic staple, it continues to generate substantial revenue, especially as combination therapies.

The genericization of both drugs significantly compressed profit margins, but widespread prescribing ensures stable revenue streams due to volume.

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Emerging Market Trends and Drivers

1. Patent Expirations and Generic Competition:
The expiration of patents for hydrochlorothiazide in the late 2000s precipitated a price collapse, prompting price wars among generic manufacturers. This trend has persisted, with only a few branded formulations maintaining premium pricing.

2. Adoption of Fixed-Dose Combinations (FDCs):
The integration of captopril and hydrochlorothiazide into FDCs enhances patient compliance and simplifies therapy. The growth in these combinations has bolstered market sales, especially in regions with rising hypertension prevalence.

3. Shift to Newer Therapeutics:
Innovations like angiotensin receptor blockers (ARBs) and calcium channel blockers have cannibalized market share from traditional agents like captopril, driven by perceptions of superior tolerability and fewer adverse effects.

4. Regulatory Push and Cost-Effectiveness:
Healthcare policies emphasizing cost containment favor low-cost generics such as hydrochlorothiazide, preserving its demand even amid newer drug classes.

5. Demographic and Epidemiological Dynamics:
The global increase in hypertension prevalence, especially in Asia-Pacific and Africa, sustains demand for affordable, effective antihypertensives.

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Financial Trajectory Analysis

1. Revenue Trends:

• Captopril experienced peak revenues during the 1990s but has seen a steady decline, aligned with increased competition from newer ACE inhibitors and concerns over side effects like cough and angioedema.
• Hydrochlorothiazide maintains stable revenues, driven by its low cost and widespread use in combination therapies. Additionally, its low manufacturing costs and high volume contribute to consistent earnings.

2. Pricing Dynamics:
Patent expiry and generic proliferation have driven down prices—by as much as 80% in some markets—yet volumes compensate for reduced unit margins. For instance, in the U.S., hydrochlorothiazide's per-tablet price declined from USD 0.10 to less than USD 0.02 over a decade.

3. Market Entry and Competition:
Market entry barriers for both drugs are low post-patent expiry. Multiple manufacturers supply these medications, leading to competitive pricing and limited differentiation.

4. Impact of Biosimilars and Alternatives:
While biosimilars are more relevant for biologics, their influence on traditional small-molecule drugs like captopril and hydrochlorothiazide remains limited. However, novel combination drugs and sustained-release formulations might carve niche markets.

5. Future Revenue Predictions:

• Captopril: Likely to witness further declines unless repositioned for niche indications or combined into innovative delivery systems.
• Hydrochlorothiazide: Expected to sustain steady revenues unless replaced by more potent diuretics or combination therapies with superior efficacy.

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Market Challenges and Opportunities

Challenges:

• Declining profitability due to price erosion post-patent expiration.
• Competition from newer drug classes with better safety profiles.
• Regulatory constraints concerning drug safety, especially with ACE inhibitors.
• Prescriber and patient preference shifts favoring newer or combination agents with improved side effect profiles.

Opportunities:

• Development of combination therapies integrating these agents with novel drugs to improve adherence.
• Expansion in untapped emerging markets where affordable, effective antihypertensives are in high demand.
• Strategic alliances and licensing opportunities focusing on formulations enhancing delivery and compliance.

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Concluding Outlook and Strategic Implications

The financial and market prospects for captopril and hydrochlorothiazide hinge primarily on macroeconomic factors, regulatory environments, and evolving clinical preferences. While the traditional dominance of these drugs is waning due to newer therapeutics, their role in combination therapy and cost-sensitive markets sustain their importance.

Manufacturers should prioritize innovation in combination formulations and seek pathways to differentiate within the commoditized landscape. Similarly, healthcare providers and policymakers should balance affordability with clinical efficacy, ensuring these foundational drugs remain accessible.

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Key Takeaways

• Boombust Cycle Post-Patent: High revenues following initial launch gave way to declining margins due to patent expirations and generic competition.
• Market Stability Through Volume: Despite low per-unit prices, high prescription volumes sustain ongoing revenue streams, especially for hydrochlorothiazide.
• Emerging Market Growth: Rapid hypertensive disease burden in emerging markets offers growth opportunities, contingent on affordable formulations.
• Innovation Focus: The future hinges on developing combination therapies and delivery systems that enhance adherence and clinical outcomes.
• Regulatory and Market Risks: Ongoing safety concerns and market commoditization pose risks; strategic diversification is essential.

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FAQs

1. What factors led to the decline in captopril’s market share?
   The decline stems from the advent of newer ACE inhibitors with better safety profiles, safety concerns related to side effects, and increasing competition from generics and alternative classes.

2. Why does hydrochlorothiazide remain widely used despite newer diuretics?
   Its low cost, proven efficacy, extensive clinical experience, and favorable safety profile sustain its demand, especially in resource-limited settings.

3. How do patent expirations influence the financial trajectory of these drugs?
   Patent expirations open markets to generics, drastically reducing prices and profit margins but typically maintaining sales volumes, which stabilizes overall revenues.

4. What role do combination therapies play in the future of these drugs?
   Combining captopril or hydrochlorothiazide with other antihypertensives enhances adherence, reduces pill burden, and can reinvigorate their market with premium formulations.

5. Are there emerging therapeutic trends that threaten the dominance of these drugs?
   Yes. The rise of ARBs, novel drug delivery systems, and personalized medicine approaches could further displace traditional drugs unless they adapt strategically.

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References

[1] MarketWatch, "Global Antihypertensive Drugs Market," 2022.