Fosinopril sodium - Generic Drug Details

What are the generic sources for fosinopril sodium and what is the scope of patent protection?

Fosinopril sodium is the generic ingredient in four branded drugs marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Invagen Pharms, Prinston Inc, Ranbaxy Labs Ltd, Teva, Upsher Smith Labs, Watson Labs, Bristol Myers Squibb, Ani Pharms, Aurobindo Pharma, Mylan, Sandoz, and Sun Pharm Inds Ltd, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for fosinopril sodium. Seven suppliers are listed for this compound.

Summary for fosinopril sodium

US Patents:	0
Tradenames:	4
Applicants:	16
NDAs:	22
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	5
Drug Prices:	Drug price trends for fosinopril sodium
What excipients (inactive ingredients) are in fosinopril sodium?	fosinopril sodium excipients list
DailyMed Link:	fosinopril sodium at DailyMed

See drug prices for fosinopril sodium

See drug sales revenues for fosinopril sodium

Recent Clinical Trials for fosinopril sodium

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

Sponsor	Phase
The First Affiliated Hospital of Anhui Medical University	Phase 4
First Affiliated Hospital of Zhejiang University	Phase 4
The Second Affiliated Hospital of Dalian Medical University	Phase 4

See all fosinopril sodium clinical trials

Pharmacology for fosinopril sodium

Drug Class	Angiotensin Converting Enzyme Inhibitor
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors

Medical Subject Heading (MeSH) Categories for fosinopril sodium

Angiotensin-Converting Enzyme Inhibitors

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for fosinopril sodium

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Ltd	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	076739-001	Dec 17, 2004		DISCN	No	No
Apotex	FOSINOPRIL SODIUM	fosinopril sodium	TABLET;ORAL	076906-003	May 17, 2005		DISCN	No	No
Teva	FOSINOPRIL SODIUM	fosinopril sodium	TABLET;ORAL	076139-002	Nov 25, 2003	AB	RX	No	No
Invagen Pharms	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	090228-002	Jul 9, 2009	AB	RX	No	No
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994		DISCN	Yes	No
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-002	May 16, 1991		DISCN	Yes	No

Expired US Patents for fosinopril sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-004	Mar 28, 1995	4,337,201*PED
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-002	May 16, 1991	4,337,201*PED
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-004	Mar 28, 1995	4,384,123
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-004	Mar 28, 1995	5,006,344*PED
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-003	May 16, 1991	5,006,344*PED
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-003	May 16, 1991	4,337,201*PED

Market Dynamics and Financial Trajectory for Fosinopril Sodium

Last updated: July 27, 2025

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Introduction

Fosinopril sodium, an angiotensin-converting enzyme (ACE) inhibitor, plays a critical role in managing hypertension and congestive heart failure. Since its development, fostinopril has carved a niche within the cardiovascular therapeutic landscape, competing with established ACE inhibitors like enalapril and lisinopril. This article examines the current market dynamics, growth drivers, challenges, and financial trajectory impacting fostinopril sodium, offering insights vital for stakeholders in pharmaceutical innovation, investment, and strategic planning.

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Market Overview and Therapeutic Significance

Fosinopril sodium was approved for medical use in several countries in the late 1990s. Its unique pharmacokinetic profile, including a dual excretion pathway (hepatic and renal), is advantageous in patients with renal impairment or hepatic dysfunction—factors that distinguish it within the ACE inhibitor class[1].

Despite its clinical benefits, fostinopril’s adoption remains limited relative to dominant agents, primarily due to market penetration barriers, patent expirations, and preset prescribing habits. Nonetheless, the drug continues to serve niche patient populations, underpinning its persistent relevance.

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Market Dynamics

1. Competitive Landscape

The global ACE inhibitor segment is mature, with key players like Pfizer, Merck, and Novartis dominating. Fosinopril holds a marginal share owing to the widespread use of drugs such as ramipril and perindopril, which benefit from extensive brand recognition and extensive clinical data[2].

Furthermore, the emergence of angiotensin receptor blockers (ARBs) and novel antihypertensive agents has diluted ACE inhibitor market growth. The increasing preference for ARBs in patients intolerant to ACE inhibitors has shifted prescribing patterns away from fosinopril and rival drugs.

2. Regulatory and Patent Environment

Fosinopril's patent life has expired in many jurisdictions, leading to the proliferation of generic versions that exert downward pressure on pricing and revenues. Generic entry typically leads to an immediate decline in drug revenue, as seen with other ACE inhibitors[3].

Regulatory authorities, such as the FDA and EMA, continue to enforce stringent efficacy and safety standards. While subjective repositioning and supplemental indications are potential strategies, they are often resource-intensive with uncertain returns.

3. Market Segments and Geographic Distribution

The drug’s market is concentrated in North America, Europe, and parts of Asia-Pacific. Developed markets contribute substantial revenues due to established healthcare infrastructure and high prevalence of hypertension. However, markets with emerging economies show potential for growth, driven by increasing hypertension awareness and rising healthcare access.

4. Demographic and Epidemiological Trends

The global rise in cardiovascular disease prevalence, fueled by aging populations and lifestyle factors, sustains demand for antihypertensive therapies. However, market growth for fostinopril specifically is constrained by competition, generics, and the advent of new classes of medications.

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Financial Trajectory

1. Revenue Trends

Historical data indicates that fostinopril sodium achieved peak revenues in the early 2010s, prior to generic market entry. Post-patent expiry, revenues declined sharply, mirroring trends observed with similar drugs. Industry estimates suggest a compound annual growth rate (CAGR) near -3% for ACE inhibitors globally over the last five years[4].

2. Cost Structure and Profitability

R&D expenditures for fostinopril’s original development have long been amortized. Current costs are limited to manufacturing, marketing, and regulatory compliance. As a generic product, profit margins are modest, with intense price competition further constraining profitability.

3. Future Revenue Projections

Given patent expiry and market saturation, future revenues are projected to decline or plateau unless repositioning occurs. Small niche markets, especially in transplantation or hypertensive crises, might yield marginal revenue with targeted marketing efforts.

Emerging market growth may bolster overall demand, but price erosions driven by generics and competition limit upside potential. Strategic alliances, such as licensing or co-marketing agreements in emerging economies, could offer incremental revenue streams.

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Market Challenges and Opportunities

Challenges

• Intense Competition: Dominance of established ACE inhibitors and ARBs restricts market share growth.
• Generic Competition: Expiration of patents leads to commoditization, pressure on margins.
• Limited Innovation Pipeline: Fosinopril’s pharmacological profile offers little differentiation, reducing attractiveness for line extensions.
• Regulatory Barriers: Approval of new indications or formulations faces high hurdles and resource requirements.

Opportunities

• Niche Indications: Exploring applications in specific subgroups, such as patients with hepatic or renal impairment, may offer targeted growth.
• Regional Expansion: Penetrating emerging markets with lower competition and growing cardiovascular care infrastructure.
• Manufacturing Optimization: Cost efficiencies through contract manufacturing and process improvements.
• Combination Therapy Formulations: Potential development of fixed-dose combinations with other antihypertensives.

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Strategic Implications

Stakeholders must approach fostinopril sodium within a broader strategic framework emphasizing lifecycle management. Investment in clinical research to differentiate the drug, partnerships in emerging economies, and formulation innovation could unlock new revenue prospects.

Pharmaceutical companies might consider repositioning fostinopril as part of combination therapies or explore its utility in specific patient populations with unmet needs. Alternatively, divestment or licensing agreements present exit or revenue-shaping strategies with less risk.

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Key Takeaways

• The market for fostinopril sodium is primarily defined by generic competition, leading to revenue declines.
• Growth opportunities in niche indications and emerging markets are limited but present strategic avenues.
• The ongoing prevalence of hypertension enhances the overall ACE inhibitor market, but fostinopril faces stiff competition.
• Cost-effective manufacturing and targeted marketing are essential for maintaining profitability.
• Inaction may accelerate revenue erosion, highlighting the need for strategic repositioning or exit strategies.

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FAQs

1. Why has fostinopril sodium's market share declined significantly?
Patent expiration and the rise of generic ACE inhibitors and ARBs have led to increased price competition and reduced brand loyalty, diminishing fostinopril's market share.

2. Are there specific patient populations where fostinopril is preferred over other ACE inhibitors?
Fosinopril’s dual excretion pathway makes it suitable for patients with renal or hepatic impairment, but overall clinical preferences favor more established agents unless specific contraindications exist.

3. Can fostinopril sodium's formula be modified or repurposed for new indications?
Drug repositioning is possible but limited by pharmacokinetic properties, existing patent statuses, and regulatory pathways. Focused clinical trials would be necessary for new indications.

4. What strategic measures can improve fostinopril's financial standing?
Targeted niche marketing, expanding geographic reach, and developing combination formulations can help optimize revenues, particularly in emerging markets.

5. What is the outlook for the ACE inhibitor market overall?
While mature in developed regions, the global ACE inhibitor market is expected to sustain demand driven by cardiovascular disease prevalence, but growth will depend heavily on innovation and clinical positioning strategies.

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References

[1] Pharmacology Review of Fosinopril, USFDA. (2000).
[2] Market Share Analysis for ACE inhibitors, IQVIA. (2022).
[3] Patent expiration impact studies, IMS Health. (2021).
[4] Global antihypertensive market report, Grand View Research. (2022).