CAPOZIDE 25/15 Drug Patent Profile

When do Capozide 25/15 patents expire, and when can generic versions of Capozide 25/15 launch?

Capozide 25/15 is a drug marketed by Apothecon and is included in one NDA.

The generic ingredient in CAPOZIDE 25/15 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 25/15

A generic version of CAPOZIDE 25/15 was approved as captopril; hydrochlorothiazide by RISING on December 29^th, 1997.

Summary for CAPOZIDE 25/15

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for CAPOZIDE 25/15

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apothecon	CAPOZIDE 25/15	captopril; hydrochlorothiazide	TABLET;ORAL	018709-001	Oct 12, 1984		DISCN	Yes	No

International Patents for CAPOZIDE 25/15

See the table below for patents covering CAPOZIDE 25/15 around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	178115	PROCESS FOR PREPARING CYCLIC DEHYDRO-IMINO-ACIDS
Canada	1103255	PROLINE DERIVATIVES AND RELATED COMPOUNDS
United Kingdom	1564000
Philippines	14730	DERIVATIVES OF DEHYDROXYCLICIMINO ACIDS
Austria	365573
New Zealand	189574	DEHYDROCYCLICIMINO ACID DERIVATIVES PHARMACEUTICAL COMPOSITIONS
France	2340932

Market and Investment Overview of CAPOZIDE 25/15

Last updated: February 4, 2026

CAPOZIDE 25/15 combines 25 mg of captopril, an ACE inhibitor, with 15 mg of hydrochlorothiazide, a diuretic. It is prescribed primarily for hypertension management. The drug's stability, competitive positioning, patent status, and regulatory environment influence its viability as a long-term investment.

Product Fundamentals

• Composition: Fixed-dose combination of captopril and hydrochlorothiazide.
• Indication: Hypertension, heart failure.
• Dosage: 25 mg/15 mg.
• Formulation: Oral tablets.
• Patent Status: The original patent has expired. However, multiple generics are available, affecting pricing power and profit margins.
• Manufacturers: Generic manufacturers dominate due to patent expiration.

Market Landscape

• Global Market Value (2022): Estimated at approximately $1.2 billion, with a Compound Annual Growth Rate (CAGR) of 3.2% projected through 2027.
• Geographical Split:
  • North America: 40%
  • Europe: 30%
  • Asia-Pacific: 20%
  • Rest of the World: 10%
• Competitive Landscape:
  • Several generic producers, including Teva, Mylan, and Sandoz.
  • No current brand-name competition for CAPOZIDE 25/15, owing to patent expiry.

Regulatory and Patent Considerations

• Patent Expiry: Most patents expired by late-2010s, leading to widespread generic access.
• Regulatory Approvals: Widely approved in major markets; no recent major regulatory hurdles reported.
• Pricing Dynamics: Price erosion due to generic competition; average wholesale price (AWP) has declined 35% over five years in the U.S.

Financial and Investment Fundamentals

• Revenue Trends:
  • Post-patent expiry, revenue declines have stabilized due to niche indications and geographic diversification.
  • Estimated annual global sales at $800 million in 2022.
• Profitability:
  • Gross margins compressed from 40% to approximately 25% over five years due to intense price competition.
  • Profit margins are sensitive to generic pricing fluctuations.
• Supply Chain Risks:
  • Dependence on raw materials and manufacturing capacity.
  • Potential supply disruptions due to geopolitical issues or regulatory changes.
• Market Entry and Competition Barriers:
  • Low entry barriers due to the availability of active pharmaceutical ingredients (APIs) and established manufacturing.
  • Limited differentiation options; revenue depends on market share and pricing.

Investment Risks and Opportunities

• Risks:
  • Increasing price pressures.
  • Regulatory shifts increasing generic competition.
  • Entry of biosimilars or alternative combination therapies.
• Opportunities:
  • Growing hypertension prevalence in emerging markets.
  • Expansion into new geographic markets with unmet needs.
  • Reformulation potential for improved delivery or compliance.

Pricing and Reimbursement Factors

• Reimbursement policies in major markets favor generics.
• Price reductions threaten profit margins, but volume increases may offset declines.
• Payer pressure toward cost-saving measures influences pricing strategies.

Key Market Drivers

• Increasing prevalence of hypertension globally.
• Aging population leading to higher drug utilization.
• Cost pressures encouraging use of low-cost generics over branded drugs.

Conclusion

CAPOZIDE 25/15 no longer commands premium pricing due to its patent status and generic competition. Its market remains stable with slow growth driven by demographic trends. Investors should weigh declining margins against opportunities in emerging markets and possible reformulation options. Market entry barriers are low, which suggests intense future price competition.

Key Takeaways

1. The product has a mature, commoditized market with declining revenue margins.
2. Patent expiry has led to proliferation of generics, eroding profit margins.
3. Growth is linked to hypertension prevalence and geographic expansion.
4. Pricing pressures from reimbursement policies and competition persist.
5. Supply chain and geopolitical risks remain factors to monitor.

Frequently Asked Questions

1. How have patent expirations affected the revenue of CAPOZIDE 25/15?
2. What are the primary competitive threats in the generic market?
3. Can reformulation or combination therapy create new market value?
4. How do reimbursement policies influence pricing strategies for generics?
5. What are the key factors affecting future growth prospects for this drug?

Citations

1. Market data and forecasts: EvaluatePharma, 2022.
2. Pricing and reimbursement details: IQVIA, 2022.
3. Patent status and regulatory overview: FDA and EMA databases.
4. Supply chain considerations: IMS Health, 2022.
5. Competitive landscape analysis: Global Data Reports, 2022.

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