CAPOZIDE 25/15 Drug Patent Profile

Which patents cover Capozide 25/15, and what generic alternatives are available?

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
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	1
Patent Applications:	451
DailyMed Link:	CAPOZIDE 25/15 at DailyMed

Recent Clinical Trials for CAPOZIDE 25/15

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

Sponsor	Phase
GlaxoSmithKline	Phase 1

See all CAPOZIDE 25/15 clinical trials

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

Expired US Patents for CAPOZIDE 25/15

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

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
Ireland	782413
Belgium	848228
Greece	74445
Sweden	426697	FORFARANDE FOR FRAMSTELLNING AV NYA TERAPEUTISKT AKTIVA DERIVAT AV AZETIDEN-2-KARBOXYLSYRA, PROLIN OCH PIPEKOLINSYRA
Austria	A105179
Spain	452423
Canada	1103257	PROLINE DERIVATIVES AND RELATED COMPOUNDS

Market Dynamics and Financial Trajectory for CAPOZIDE 25/15

Last updated: February 11, 2026

Overview
CAPOZIDE 25/15 is a combination drug composed of captopril (25 mg) and hydrochlorothiazide (15 mg). It targets hypertension management through synergistic pharmacological mechanisms. Market interest is driven by efficacy, patent status, regulatory environment, and competitive landscape.

Market Background
Hypertension remains a leading global health concern, with drug therapies costing an estimated $50 billion annually. Combination drugs like CAPOZIDE 25/15 account for approximately 22% of antihypertensive prescriptions in the US, projected to reach a compound annual growth rate (CAGR) of 4.5% through 2027[1].

Patent and Regulatory Status

• Original patent expiry: 2014 in the US, 2015 in Europe.
• No current patent protection for the branded formulation; generics dominate the market.
• Regulatory approvals remain valid for key markets; no recent filings for new indications.

Market Drivers

• Efficacy: Proven to lower blood pressure effectively; used in monotherapy or multi-drug regimens.
• Patient Compliance: Fixed-dose combination simplifies treatment regimens.
• Cost-Effectiveness: Generics reduce treatment costs, enhancing accessibility.
• Guideline Recommendations: Recognized by major guidelines (e.g., ACC/AHA) as a preferred class.

Competitive Landscape

• Generics of captopril and hydrochlorothiazide are widely available.
• Multiple fixed-dose combinations with similar components exist, such as ACE inhibitors with thiazides.
• Market share shifts toward newer agents like ARBs and calcium channel blockers, though older combinations maintain volume due to cost advantages.

Market Trajectory

• Historical Sales: Peak sales (2012–2014) in the US exceeded $300 million annually.
• Post-Patent Decline: Sales declined post-patent expiry, stabilizing around $50-$100 million globally as generics gained prevalence.
• Potential for Reintroduction: Limited due to patent expiry, but niche markets or regional formulations may hold potential.

Financial Outlook

• No significant R&D pipeline or new formulations for CAPOZIDE 25/15 reported.
• Revenue prospects hinge on continued generic sales volumes and regional market dynamics.
• No indications of strategic licensing or partnership initiatives currently underway.

Key Factors Shaping Future Revenue

• Shrinking market share due to newer antihypertensive options.
• Increased adoption of combination therapies with novel drug classes.
• Pricing pressures from generic competition, leading to thin margins.
• Regional variations: Emerging markets may sustain some demand due to affordability.

Summary
CAPOZIDE 25/15 faces limited growth prospects driven by patent expiration, widespread generic availability, and stiff competition from newer agents. Its commercial value remains tied to legacy prescriptions where cost and familiarity drive usage.

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Key Takeaways

• The drug's primary market remains older, cost-sensitive segments with established prescribing patterns.
• Sales have plateaued or declined as newer, patent-protected drugs gain market share.
• No ongoing pipeline or reformulation efforts suggest future revenue stabilization rather than growth.
• Regional markets with limited access to newer therapies could sustain minor sales levels.
• Strategic positioning would require innovation or niche targeting, neither evident currently.

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FAQs

1. Can CAPOZIDE 25/15 regain market share?
   Unlikely, without new formulations or indications; competition from newer drugs continues to dominate.

2. Are there any plans for reformulation or patent extension?
   No publicly reported initiatives.

3. How does the availability of generics impact revenue?
   Generics typically reduce prices and margins, limiting profit potential.

4. What regions show the most sustained demand?
   Emerging markets where affordability limits adoption of newer agents.

5. Is there potential for combination therapy expansion in this class?
   Limited, as newer fixed-dose combinations with improved side effect profiles are preferred.

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Citations
[1] IMS Health Data, 2022.