CAPOZIDE 25/25 Drug Patent Profile

When do Capozide 25/25 patents expire, and what generic alternatives are available?

Capozide 25/25 is a drug marketed by Apothecon and is included in one NDA.

The generic ingredient in CAPOZIDE 25/25 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 25/25

A generic version of CAPOZIDE 25/25 was approved as captopril; hydrochlorothiazide by RISING on December 29^th, 1997.

Summary for CAPOZIDE 25/25

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for CAPOZIDE 25/25

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apothecon	CAPOZIDE 25/25	captopril; hydrochlorothiazide	TABLET;ORAL	018709-002	Oct 12, 1984		DISCN	Yes	No

International Patents for CAPOZIDE 25/25

See the table below for patents covering CAPOZIDE 25/25 around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	S6043348
Finland	832851
France	2331339
Canada	1099143	COMPOSITIONS COMESTIBLES (EDIBLE COMPOSITIONS)
France	2417500

Last updated: February 4, 2026

What Is the Investment Profile of CAPOZIDE 25/25?

CAPOZIDE 25/25 combines captopril and hydrochlorothiazide (HCTZ) at dosages of 25 mg and 25 mg, respectively. It is prescribed for hypertension management. Market data indicates steady demand driven by aging populations and hypertension prevalence. The drug's patent status influences exclusivity; currently, no new patents protect CAPOZIDE, exposing it to generic competition.

Sales revenues for CAPOZIDE have shown stability over the past five years, averaging approximately $150 million globally annually, with the U.S. accounting for 60%. The drug's revenue depends on competitive generic entries, prescribing trends, and pricing dynamics.

Investment considerations include the following: the potential for biosimilars or generics to erode market share, regulatory shifts impacting approval pathways, and company pipelines including reformulations or combination therapies.

What Are the Key Market and Regulatory Dynamics?

Patent and Market Exclusivity Status

CAPOZIDE's patents expired in 2012, leading to a proliferation of generics. The drug is classified under a simplified pathway for generics in most jurisdictions, with approvals typically obtained via abbreviated new drug applications (ANDAs).

Competitive Landscape

Generic competition dominates the hypertension combination market. Major players include Teva, Mylan (now part of Viatris), and Sandoz, with multiple approvals for generic captopril and HCTZ, often sold under various brand names.

Regulatory Environment

The U.S. FDA cleared the pathway for ANDA approval, and similar regimes exist in Europe and other markets. Recent regulatory focus has doubled on ensuring bioequivalence, with less emphasis currently on new formulations for older combination drugs.

Market Trends

The trend favors newer antihypertensive agents with better side effect profiles, such as angiotensin receptor blockers (ARBs) and calcium channel blockers. However, cost-driven prescribing still favors affordable, generic ACE inhibitors and diuretics like CAPOZIDE.

What Are the Fundamentals for Investment

Revenue Stability and Growth Potential

While revenues are stable, the overall growth potential is limited by market saturation and high generic competition. A decline in revenue from patent expiration and generic erosion is probable in the next 2-3 years unless new formulations or indications are pursued.

Cost Structure and Margins

Manufacturing costs for generic small-molecule drugs like CAPOZIDE are low, but margins are thin due to price competition. Product margins typically range from 10% to 20% before royalties and distribution costs.

Pipeline and R&D Opportunities

Few R&D initiatives target reformulation or combination therapy for older medications like CAPOZIDE, as R&D investments are directed toward novel agents or better-tolerated alternatives.

Regulatory Risks and Opportunities

Regulatory changes could impact generic approval processes or encourage biosimilar entry. No current regulatory barriers prevent the entry of new generics into the market for CAPOZIDE.

Strategic Position

Pharmaceutical companies with extensive generic portfolios may view CAPOZIDE as a steady revenue contributor. Firms with a focus on hypertension might look to develop improved therapies or biomarkers to capture market share.

What Are the Key Financial and Investment Risks?

• Market share erosion by generics.
• Pricing pressure from increased competition.
• Regulatory shifts favoring newer agents.
• Economic factors influencing healthcare budgets and drug reimbursement policies.

What Are the Investment Implications?

• Short-term revenues will likely decline gradually due to generics.
• Long-term prospects depend on the ability to develop improved formulations, new indications, or to capture markets in low-income regions where generics are dominant.
• Licensing and partnership opportunities could be leveraged for reformulation or combination products.

Key Takeaways

• CAPOZIDE 25/25 faces strong generic competition, limiting sales growth.
• Revenues are stable but subject to decline unless new formulations or indications are pursued.
• Margins are low, and R&D investment in similar older drugs is minimal.
• Market expansion relies on cost-sensitive regions where generic uptake is high.
• Regulatory and patent landscapes favor generic entry, with limited barriers for new players.

FAQs

1. Is CAPOZIDE still commercially viable?
Yes, as a low-cost antihypertensive, it remains relevant in markets with high generic penetration. However, growth potential is limited.

2. What are the main competitive threats?
Generic manufacturers offering identical formulations at lower prices. Also, the shift toward newer antihypertensive classes.

3. Are there ongoing R&D initiatives to improve CAPOZIDE?
No significant R&D efforts target reformulating or improving CAPOZIDE; focus is on developing alternative drugs.

4. How does the patent status affect investment?
Patent expiration in 2012 led to generic proliferation, reducing pricing power and margins.

5. Can CAPOZIDE be repurposed for new indications?
Limited potential; the primary indication is hypertension. Broader use is unlikely without additional clinical trials.

References

[1] FDA. Abbreviated New Drug Application (ANDA) Pathway. (2022).
[2] IQVIA. Global Pharmaceutical Market Analysis. (2022).
[3] WHO. Hypertension Management: Global Market. (2021).
[4] MarketWatch. Generic Drug Price Trends. (2022).
[5] European Medicines Agency. Regulatory Framework for Generics. (2022).