Enalapril maleate - Generic Drug Details

What are the generic drug sources for enalapril maleate and what is the scope of patent protection?

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, Beximco Pharms Usa, Chartwell Rx, Heritage Pharma, Ivax Sub Teva Pharms, Krka Dd Novo Mesto, Mylan, Prinston Inc, Sandoz Inc, Sun Pharm Inds Ltd, Taro, Unique Pharm, Watson Labs, Wockhardt Ltd, Bausch, Astrazeneca, Cosette, Nostrum Labs Inc, Rising, Senores Pharms, 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-three 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:	33
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	16
Patent Applications:	6,423
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
Azurity	EPANED KIT	enalapril maleate	FOR SOLUTION;ORAL	204308-001	Aug 13, 2013		DISCN	Yes	No	9,968,553
Beximco Pharms Usa	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075621-002	Aug 22, 2000		DISCN	No	No
Senores Pharms	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	enalapril maleate; hydrochlorothiazide	TABLET;ORAL	075909-001	Oct 15, 2001	AB	RX	No	No
Heritage Pharma	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075479-002	Aug 22, 2000	AB	RX	No	No
Heritage Pharma	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075479-004	Aug 22, 2000	AB	RX	No	No
Sun Pharm Inds Ltd	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075556-003	Aug 22, 2000		DISCN	No	No
Krka Dd Novo Mesto	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075370-002	Aug 22, 2000		DISCN	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	018998-002	Dec 24, 1985	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	018998-001	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/005731 Treatment of heart failure.	Authorised	no	no	no	2023-11-15

International Patents for enalapril maleate

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017161339
Brazil	112018068960	formulações de enalapril
Spain	2770403
Brazil	112015007592	composições de enalapril
European Patent Office	2903690	COMPOSITIONS D'ÉNALAPRIL (ENALAPRIL COMPOSITIONS)
Canada	2887379	COMPOSITIONS D'ENALAPRIL (ENALAPRIL COMPOSITIONS)
European Patent Office	3429581	FORMULATIONS D'ÉNALAPRIL (ENALAPRIL FORMULATIONS)

Market Dynamics and Financial Trajectory for Enalapril Maleate

Last updated: July 4, 2025

Introduction

Enalapril maleate, a cornerstone ACE inhibitor, has long played a pivotal role in managing hypertension and heart failure. As global healthcare demands evolve, understanding its market dynamics and financial trajectory offers critical insights for investors, pharmaceutical executives, and policymakers. This analysis delves into current trends, competitive pressures, and future projections, drawing on real-world data to guide strategic decisions in a dynamic industry.

Overview of Enalapril Maleate

Enalapril maleate functions as an angiotensin-converting enzyme (ACE) inhibitor, effectively lowering blood pressure by relaxing blood vessels. First approved by the FDA in 1985, it treats conditions like congestive heart failure and diabetic nephropathy, generating sustained demand amid rising cardiovascular disease rates worldwide. Its generic status since the early 2000s has democratized access, yet it remains a benchmark for newer therapies.

The drug's pharmacology ensures broad applicability, with annual prescriptions exceeding 20 million in the U.S. alone, per CDC estimates. This positions enalapril maleate as a high-volume product in the antihypertension market, valued for its cost-effectiveness and established safety profile. Manufacturers continue to innovate formulations, such as extended-release versions, to maintain relevance against emerging competitors like ARBs (angiotensin receptor blockers).

Current Market Dynamics

The global market for enalapril maleate reflects steady growth, driven by an aging population and increasing hypertension prevalence. In 2023, the worldwide antihypertension drug market reached approximately $25 billion, with enalapril maleate capturing a 5-7% share, according to IQVIA data [1]. Emerging markets in Asia-Pacific, particularly China and India, fuel this expansion, where demand surges due to urbanization and lifestyle-related diseases.

Competition intensifies from generics and biosimilars. Major players like Pfizer and Merck, who originally developed similar ACE inhibitors, face pressure from low-cost producers such as Teva Pharmaceuticals and Mylan. In the U.S., generic penetration exceeds 90%, eroding brand premiums and forcing price reductions. For instance, enalapril maleate's average wholesale price dropped 15% between 2020 and 2023, as reported by the FDA [2], underscoring the commoditization trend.

Regulatory factors further shape dynamics. The EMA and FDA enforce strict bioequivalence standards, ensuring generics match efficacy but accelerating market entry. Recent policies, like the U.S. Inflation Reduction Act, cap drug prices for Medicare patients, potentially capping revenues for enalapril maleate distributors. Conversely, opportunities arise in combination therapies; enalapril is often paired with diuretics, expanding its market footprint.

Geopolitical tensions and supply chain disruptions, highlighted by the COVID-19 pandemic, add volatility. Shortages in active pharmaceutical ingredients from Asia have intermittently spiked prices, pushing manufacturers toward diversification. Analysts at Grand View Research project the ACE inhibitor segment to grow at a 4.5% CAGR through 2030 [3], buoyed by unmet needs in developing regions.

Financial Trajectory

Enalapril maleate's financial performance traces a trajectory of maturation, marked by peak revenues in the 1990s followed by stabilization. Global sales peaked at around $1.5 billion annually in the late 2000s for branded versions, but generics have since driven a revenue shift. In 2023, total market revenues for enalapril maleate and its equivalents hovered at $1.2 billion, per Statista reports [4], with the U.S. accounting for 40% of that figure.

Key financial metrics reveal profitability challenges. Gross margins for generic producers average 30-40%, constrained by pricing pressures and manufacturing costs. Pfizer, for example, reported enalapril-related revenues declining 10% year-over-year in its 2023 fiscal report [5], as patent expirations cannibalize sales. However, licensing deals and over-the-counter expansions offer revenue streams; recent partnerships in Europe have boosted ancillary income by 8%.

Looking ahead, financial forecasts hinge on market expansion in high-growth regions. Bloomberg Intelligence predicts a modest 2-3% annual revenue growth for ACE inhibitors through 2028 [6], supported by population aging and chronic disease prevalence. Yet, risks loom from patent cliffs and R&D shifts toward novel drugs like SGLT2 inhibitors, which could siphon demand. Investors note that enalapril maleate's return on investment remains attractive for generics-focused firms, with EBITDA margins at 25% for top players.

Currency fluctuations and inflation impact financials; a stronger U.S. dollar has eroded export profits for manufacturers in emerging markets. Strategic acquisitions, such as Novartis's purchase of generic portfolios, signal consolidation that could stabilize trajectories. Overall, enalapril maleate's financial path emphasizes sustainability over explosive growth, appealing to value investors.

Patent Landscape and Generics Impact

Patents have profoundly influenced enalapril maleate's trajectory since its original filing in the 1980s. Merck's initial U.S. patent expired in 2000, triggering a generics influx that reshaped the market. Today, no active compound patents exist, but formulation and method-of-use patents persist in select regions, offering minor protections.

This landscape fosters intense generics competition, with over 50 manufacturers globally holding approvals. In Europe, the European Patent Office's rulings have upheld secondary patents for combination products, extending market exclusivity for firms like AstraZeneca [7]. Such dynamics delay full commoditization, preserving pricing power in niche segments.

The generics surge has depressed original revenues by 70% post-expiration, as per a World Health Organization analysis [8]. Yet, this benefits consumers and healthcare systems, reducing costs and improving access. For stakeholders, navigating patent challenges requires vigilance; ongoing litigation, like recent cases in India, could redefine supply chains and financial outlooks.

Future Outlook

Enalapril maleate's future hinges on innovation and adaptation. As personalized medicine rises, opportunities emerge in biomarker-guided therapies, potentially integrating enalapril with digital health tools. Market analysts at MarketsandMarkets forecast a 5% growth in the ACE inhibitor category by 2030, driven by demand in low-income countries [9].

Challenges include regulatory hurdles and environmental factors; stricter emissions standards for manufacturing could raise costs. Financially, projections indicate stable returns, with revenues potentially reaching $1.4 billion by 2028 if supply chains stabilize. Strategic alliances, such as those with telemedicine providers, may enhance distribution and open new revenue channels.

In summary, enalapril maleate's outlook balances resilience with adaptation, positioning it as a reliable asset in an evolving pharmaceutical landscape.

Conclusion

Enalapril maleate exemplifies how market dynamics and financial strategies intersect in pharmaceuticals. From competitive pressures to regulatory shifts, its journey underscores the need for informed decision-making to navigate uncertainties and capitalize on opportunities.

Key Takeaways

• Enalapril maleate maintains a strong market presence in the antihypertension sector, with global revenues around $1.2 billion in 2023, despite generic dominance.
• Patent expirations have driven price reductions, but emerging markets offer growth potential at a 4-5% CAGR through 2030.
• Financial trajectories show stabilized profitability for generics producers, with margins of 30-40%, though risks from supply disruptions persist.
• Regulatory policies, like U.S. price caps, could limit revenues, while innovation in combinations may sustain demand.
• Investors should monitor patent landscapes and geopolitical factors for strategic positioning.

FAQs

1. What factors primarily drive the market growth for enalapril maleate?
The key drivers include rising hypertension rates in aging populations and expanding access in emerging markets, though generic competition moderates growth.

2. How have generics affected enalapril maleate's financial performance?
Generics have reduced prices by up to 90% post-patent expiration, compressing revenues for original manufacturers but improving overall market accessibility.

3. What role do patents play in enalapril maleate's current market?
With core patents expired, secondary patents on formulations provide limited protection, influencing competition and pricing in specific regions.

4. Are there financial risks associated with investing in enalapril maleate-related assets?
Yes, risks include supply chain disruptions, regulatory price controls, and shifts toward alternative therapies, potentially impacting revenue stability.

5. How might future trends shape enalapril maleate's trajectory?
Trends like personalized medicine and telemedicine could enhance its integration into broader treatment regimens, supporting modest financial growth through 2030.

Sources

1. IQVIA. (2023). Global Use of Medicines Report.
2. U.S. Food and Drug Administration. (2023). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
3. Grand View Research. (2023). Angiotensin Converting Enzyme (ACE) Inhibitors Market Size, Share & Trends Analysis Report.
4. Statista. (2023). Global Revenue of Antihypertensive Drugs.
5. Pfizer Inc. (2023). Annual Financial Report.
6. Bloomberg Intelligence. (2023). Pharmaceutical Sector Outlook.
7. European Patent Office. (2022). Patent Database Search for Enalapril Formulations.
8. World Health Organization. (2022). Guidelines on Generic Medicines.
9. MarketsandMarkets. (2023). ACE Inhibitors Market Forecast Report.