Fosinopril sodium; hydrochlorothiazide - Generic Drug Details

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

Fosinopril sodium; hydrochlorothiazide is the generic ingredient in two branded drugs marketed by Ani Pharms, Aurobindo Pharma, Chartwell Rx, Invagen Pharms, Mylan, Sandoz, Sun Pharm Inds Ltd, Teva, and Bristol Myers Squibb, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for fosinopril sodium; hydrochlorothiazide

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	10
Finished Product Suppliers / Packagers:	2
Clinical Trials:	2
DailyMed Link:	fosinopril sodium; hydrochlorothiazide at DailyMed

Recent Clinical Trials for fosinopril sodium; hydrochlorothiazide

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

Sponsor	Phase
Ranbaxy Laboratories Limited	N/A

See all fosinopril sodium; hydrochlorothiazide clinical trials

Pharmacology for fosinopril sodium; 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 fosinopril sodium; 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 fosinopril sodium; hydrochlorothiazide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	076945-001	Jul 5, 2006		DISCN	No	No
Chartwell Rx	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	079025-002	Sep 17, 2010		DISCN	No	No
Ani Pharms	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	076608-001	Dec 3, 2004		DISCN	No	No
Sandoz	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	076961-001	Sep 28, 2005	AB	RX	No	No
Invagen Pharms	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	090228-001	Jul 9, 2009	AB	RX	No	No
Invagen Pharms	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	090228-002	Jul 9, 2009	AB	RX	No	No

Expired US Patents for fosinopril sodium; hydrochlorothiazide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994	4,337,201*PED
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994	5,006,344*PED
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994	4,384,123
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994	4,384,123
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994	4,337,201*PED
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994	5,006,344*PED

Fosinopril sodium; hydrochlorothiazide Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for Fosinopril Sodium; Hydrochlorothiazide?

Fosinopril sodium combined with hydrochlorothiazide is a fixed-dose combination used primarily for treating hypertension. The market for this drug hinges on several factors:

• Prevalence of Hypertension: Hypertension affects approximately 1.4 billion adults globally, with growth fueled by aging populations and increased obesity rates. The demand for antihypertensive medications continues to expand correspondingly.
• Competitive Landscape: The combination faces competition from other fixed-dose combinations (e.g., lisinopril-hydrochlorothiazide, enalapril-hydrochlorothiazide) which often are preferred due to cost, efficacy, or prescribing habits.
• Regulatory Approvals and Patent Status: Fosinopril’s patent expired in key markets around 2010, leading to a rise in generic versions. Hydrochlorothiazide is off patent, contributing to low-cost generic competition.
• Physician and Patient Preference: Doctors favor combination pills for improving adherence; however, newer classes like ARBs or ACE inhibitors combined with calcium channel blockers pose threats in certain markets.
• Pricing and Reimbursement Policies: Cost-effectiveness influences uptake, especially in cost-sensitive markets like India, Southeast Asia, and parts of Africa.

How Does the Financial Trajectory of Fosinopril Sodium; Hydrochlorothiazide Evolve?

Revenue trends reflect broader market shifts:

• Global Sales: Estimated at approximately $300 million in 2022, with generic versions accounting for a significant portion.
• Market Share: The combination holds a modest share in antihypertensive therapy. The total antihypertensive market size exceeds $20 billion globally, but this specific combination’s slice is limited due to competition.
• Pricing Trends: Prices for branded Fosinopril products ranged from $50 to $100 per month in developed markets pre-patent expiry. Generics now sell below $10 per month.
• Regional Variations: Higher adoption in Europe and North America where healthcare providers favor ACE inhibitors. Lower in low-resource regions, where affordability favors generics and simpler therapies.
• Patent Expiry Impact: Post-2010, U.S. and European patents expired, causing revenue decline for original manufacturers; sales shifted toward generics and regional manufacturers.

What Are Key Drivers and Challenges Affecting Its Market and Financial Future?

Drivers:

• Growing awareness of cardiovascular risk management.
• Physician preference for combination therapy to enhance compliance.
• Cost reduction leading to wider access in emerging markets.
• Potential for combination reformulations incorporating newer agents.

Challenges:

• Competition from newer therapies (ARBs, direct renin inhibitors).
• Strict pricing controls in public healthcare systems.
• Limited clinical advantages over other fixed-dose combinations.
• Patent expiration leading to commoditization.

How Is the Market Expected to Change Over the Next Five Years?

Forecasts suggest:

• CAGR of 2-3% for the fixed-dose combination antihypertensives market.
• Increased generic penetration reducing prices further.
• Some growth in high-burden regions due to improved healthcare access.
• Incremental shift toward newer therapy combinations and personalized medicine approaches.

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Key Takeaways

• The Fosinopril Sodium; Hydrochlorothiazide market is shrinking in premium markets due to generic competition and patent expiry.
• Global market size remains modest compared to overall antihypertensive drugs but benefits from global hypertension prevalence.
• Cost and formulary preferences heavily influence regional adoption.
• Outlook indicates slow, steady growth driven by emerging markets and improved medication adherence strategies.

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FAQs

1. What factors influence the pricing of Fosinopril-Hydrochlorothiazide formulations?
Pricing depends on brand vs. generic status, regional healthcare policies, and market competition. Generics price below $10 in many markets, while branded versions can cost tens of dollars monthly.

2. How significant is patent expiry for this combination’s market?
Patent expiration catalyzed revenue decline for original brands, leading to increased generic availability and lower prices.

3. Are there regulatory barriers to expanding the use of this drug?
Regulatory bodies require evidence of safety and efficacy; however, as a generic antihypertensive, regulatory hurdles are minimal in most markets.

4. What is the role of this combination in current hypertension management?
It remains an option for patients requiring dual therapy but faces competition from newer fixed-dose combinations with potentially better tolerability or efficacy.

5. Which emerging markets could see increased adoption?
India, Southeast Asia, and parts of Africa could see growth due to increased healthcare infrastructure and demand for affordable antihypertensive therapies.

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Sources

[1] WHO Global Status Report on Noncommunicable Diseases 2014
[2] IQVIA: Global Market Insights 2022
[3] U.S. FDA Drugs@FDA Database
[4] EvaluatePharma: 2022 World Market Trends