ENALAPRIL MALEATE - Generic Drug Details

What are the generic sources for enalapril maleate and what is the scope of freedom to operate?

Enalapril maleate is the generic ingredient in seven branded drugs marketed by Azurity, Alkem Labs Ltd, Amneal, Annora Pharma, Aurobindo Pharma, Bionpharma, Aiping Pharm Inc, Apothecon, Aurobindo Pharma Usa, Chartwell Rx, Heritage Pharma, Ivax Sub Teva Pharms, Krka Dd Novo Mesto, Mylan, Prinston Inc, Regcon Holdings, Sandoz Inc, Senores Pharms, Sun Pharm Inds Ltd, Taro, Unique Pharm, Watson Labs, Bausch, Astrazeneca, Anda Repository, Cosette, Mpp Pharma, Rising, and Taro Pharm Inds, and is included in thirty-five NDAs. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Enalapril maleate has eight patent family members in five countries.

There are eighteen drug master file entries for enalapril maleate. Thirty-five suppliers are listed for this compound.

Summary for ENALAPRIL MALEATE

International Patents:	8
US Patents:	13
Tradenames:	7
Applicants:	29
NDAs:	35
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	16
Patent Applications:	6,853
Drug Prices:	Drug price trends for ENALAPRIL MALEATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENALAPRIL MALEATE
What excipients (inactive ingredients) are in ENALAPRIL MALEATE?	ENALAPRIL MALEATE excipients list
DailyMed Link:	ENALAPRIL MALEATE at DailyMed

See drug prices for ENALAPRIL MALEATE

See drug sales revenues for ENALAPRIL MALEATE

Recent Clinical Trials for ENALAPRIL MALEATE

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

Sponsor	Phase
Manchester University NHS Foundation Trust	Phase 2
Newcastle-upon-Tyne Hospitals NHS Trust	Phase 3
South Tees Hospitals NHS Foundation Trust	Phase 3

See all ENALAPRIL MALEATE clinical trials

Pharmacology for ENALAPRIL MALEATE

Drug Class	Angiotensin Converting Enzyme Inhibitor
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors
Physiological Effect	Decreased Blood Pressure

Medical Subject Heading (MeSH) Categories for ENALAPRIL MALEATE

Angiotensin-Converting Enzyme Inhibitors

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for ENALAPRIL MALEATE

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for ENALAPRIL MALEATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPANED	Oral Solution	enalapril maleate	1 mg/mL	208686	1	2018-08-31
EPANED KIT	Powder for Oral Solution	enalapril maleate	1 mg/mL	204308	1	2016-06-21

US Patents and Regulatory Information for ENALAPRIL MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Heritage Pharma	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075479-001	Aug 22, 2000	AB	RX	No	No
Watson Labs	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075501-002	Aug 22, 2000		DISCN	No	No
Chartwell Rx	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	076116-001	Sep 19, 2001		DISCN	No	No
Aurobindo Pharma Usa	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075480-004	Aug 22, 2000		DISCN	No	No
Sandoz Inc	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075459-001	Aug 22, 2000	AB	RX	No	No

Expired US Patents for ENALAPRIL MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-005	Jul 26, 1988	4,374,829*PED
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-003	Dec 24, 1985	4,374,829*PED
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-002	Dec 24, 1985	4,374,829*PED
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-001	Dec 24, 1985	4,374,829*PED

EU/EMA Drug Approvals for ENALAPRIL MALEATE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Proveca Pharma Limited	Aqumeldi	Enalapril maleate	EMEA/H/C/005731Treatment of heart failure.	Authorised	no	no	no	2023-11-15

International Patents for ENALAPRIL MALEATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3429581	FORMULATIONS D'ÉNALAPRIL (ENALAPRIL FORMULATIONS)
Spain	2770403
European Patent Office	3429581	FORMULATIONS D'ÉNALAPRIL (ENALAPRIL FORMULATIONS)
Brazil	112018068960
Brazil	112015007592	composições de enalapril

Market Dynamics and Financial Trajectory for Enalapril Maleate

Last updated: July 27, 2025

Introduction

Enalapril maleate, an angiotensin-converting enzyme (ACE) inhibitor, is primarily prescribed for managing hypertension and congestive heart failure. Since its patent expiration, the drug has transitioned from a branded product to a widely accessible generic medication, influencing global market dynamics and financial outcomes. This report analyzes the current landscape, key drivers, competitive factors, and future financial prospects for enalapril maleate.

Market Overview

Historical Context

Enalapril maleate was first introduced in the late 1980s, initially marketed under brand names such as Vasotec (by Merck & Co.). Following patent expiration in the early 2000s, the market saw a surge in generic formulations, leading to increased accessibility and declining prices (1).

Current Market Size

Global prescriptions for enalapril and its formulations, including enalapril maleate, are estimated to exceed 100 million annually. The hypertensive population and heart failure cases underpin this demand, with markets in North America, Europe, and Asia-Pacific representing significant shares.

Geographical Market Distribution

• North America: Dominates the global market due to high hypertension prevalence and advanced healthcare infrastructure.
• Europe: Maintains a robust market owing to stringent guidelines and acceptance of ACE inhibitors.
• Asia-Pacific: Exhibits rapid growth driven by increasing urbanization, lifestyle changes, and expanding healthcare access.

Market Drivers

1. Prevalence of Hypertension and Heart Failure

The global burden of hypertension affects over 1.2 billion people, with a substantial portion prescribed enalapril maleate (2). The aging population and rising prevalence of cardiovascular diseases sustain demand.

2. Cost-Effective Alternative

Generic formulations by multiple manufacturers have made enalapril maleate an affordable option, especially in developing economies, driving volume sales.

3. Expanding Indications

Beyond hypertension, enalapril maleate finds use in diabetic nephropathy and post-myocardial infarction management, broadening its therapeutic scope.

4. Regulatory Support

Stringent guidelines promote the use of affordable ACE inhibitors as first-line therapy, reinforcing its market position (3).

Market Challenges

1. Competitive Landscape

The proliferation of generic ACE inhibitors like lisinopril and ramipril offers alternatives, intensifying competition (4).

2. Patent Protections and Exclusivity

While enalapril's patent expired decades ago, newer formulations and combinations remain protected, limiting certain market segments.

3. Safety Concerns and Side Effects

Adverse reactions such as cough and hyperkalemia, though manageable, may influence prescriber preferences and patient compliance.

4. Market Saturation

In mature markets, growth is plateauing due to saturation and potential de-prescribing trends.

Financial Trajectory and Forecasting

Historical Revenue Trends

Market analysts estimate that enalapril maleate’s global annual sales peaked between $1.5 billion and $2 billion in the early 2000s, with a subsequent decline in branded sales following patent expiry (5). Currently, the generic market sustains a steady revenue stream, approximating $1 billion annually.

Current Market Dynamics

The competitive environment has led to price erosion, with wholesale prices decreasing by approximately 20-30% over the past decade. This trend favors healthcare systems but compresses profit margins for manufacturers.

Future Market Projections

• Growth Rates: The compound annual growth rate (CAGR) for enalapril maleate is projected to be between 2-4% over the next five years, driven mainly by emerging markets.
• Market Expansion: Increased adoption in developing countries, where hypertension awareness campaigns are intensifying, may bolster demand.
• Combination Therapies: Fixed-dose combinations incorporating enalapril may offer new revenue avenues, especially in polypharmacy-managed populations.

Emerging Trends Impacting Financials

• Biosimilars and New Therapeutics: Competition from novel therapies may limit upside potential.
• Regulatory Incentives: Inclusion in national essential medicines lists enhances accessibility, sustaining demand.
• Digital Health and Telemonitoring: Improved adherence and management could prolong the drug’s lifecycle.

Competitive Landscape

Major manufacturers include Teva Pharmaceuticals, Sandoz, Mylan, and local generic producers. Market share is fragmented, with no single entity dominating globally. Price competition, quality assurance, and supply chain reliability are crucial factors differentiating competitors.

Regulatory and Patent Considerations

While patent exclusivity for enalapril expired in key markets, certain formulations and combination therapies remain under patent or exclusivity protections, influencing market entry and revenue potential. Regulatory approvals for new formulations or indications can expand market share but require significant investment.

Implications for Stakeholders

• Pharmaceutical Companies: Focus on operational efficiencies, cost reduction, and expanding indications to sustain profitability.
• Healthcare Providers: Emphasize the importance of cost-effective therapy options in population health management.
• Patients: Benefit from increased accessibility and affordability of antihypertensive therapy.
• Regulatory Bodies: Need to monitor safety profiles and promote policies that balance innovation incentives with affordability.

Conclusion

The market for enalapril maleate remains stable yet mature, characterized by steady revenue with modest growth prospects. Market dynamics, primarily driven by high prevalence of target conditions and affordability in emerging markets, support ongoing demand. Competitive pressures and increasing generic penetration pose challenges to profitability but also promote price competitiveness and access. Strategic positioning, especially in expanding markets and combination therapies, will determine future financial trajectories.

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Key Takeaways

• Market Maturity: Enalapril maleate is a mature, commoditized antihypertensive with stable worldwide demand.
• Growth Drivers: Rising cardiovascular disease burden and affordability focus on generics sustain volume.
• Competitive Pressures: Price erosion due to generics, with the threat of newer agents, limits revenue growth.
• Emerging Opportunities: Expansion into developing markets and combination therapies offer future upside.
• Strategic Focus: Manufacturers must optimize cost efficiencies and diversify offerings to maintain margins.

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FAQs

1. What factors influence the declining prices of enalapril maleate?
   The expiration of patents, increased competition among generic manufacturers, and regulatory policies favoring cost-effective therapies drive price declines.

2. Are there any new formulations or indications for enalapril maleate?
   Most formulations remain unchanged, but fixed-dose combinations and novel delivery systems are emerging in some markets, potentially expanding its therapeutic applications.

3. How does the competitive landscape affect profitability?
   High market fragmentation and aggressive pricing strategies among generic producers lead to margin compression but ensure stable volumes.

4. What role do regulatory agencies play in the future of enalapril maleate?
   Agencies influence market access through approvals, safety monitoring, and policy incentives, impacting product lifecycle and market expansion.

5. What trends could disrupt the enalapril market in the future?
   The development of new antihypertensive drugs, biosimilars, and personalized medicine approaches may reduce reliance on traditional ACE inhibitors.

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References

1. World Health Organization. Hypertension fact sheet. WHO; 2022.
2. Global Burden of Disease Study. Cardiovascular diseases. Lancet. 2021.
3. European Society of Cardiology. Guidelines on hypertension management. ESC; 2021.
4. MarketWatch. ACE inhibitors market analysis, 2022.
5. EvaluatePharma. Market intelligence for cardiovascular drugs, 2021.