Enalapril maleate - Generic Drug Details

What are the generic 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, Dr Reddys Labs Ltd, Nostrum Labs Inc, 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-four 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:	34
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	16
Patent Applications:	5,287
Drug Prices:	Drug price trends for enalapril maleate
Drug Sales Revenues:	Drug sales revenues 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
University of Durham	Phase 3
Newcastle-upon-Tyne Hospitals NHS 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
Annora Pharma	ENALAPRIL MALEATE	enalapril maleate	SOLUTION;ORAL	214467-001	Feb 24, 2022	AB	RX	No	No
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-003	Dec 24, 1985	AB	RX	Yes	Yes
Watson Labs	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075501-001	Aug 22, 2000		DISCN	No	No
Prinston Inc	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	213273-001	Jul 7, 2022	AB	RX	No	No
Krka Dd Novo Mesto	ENALAPRIL MALEATE	enalapril maleate	TABLET;ORAL	075369-001	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	018998-003	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/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
European Patent Office	2903690	COMPOSITIONS D'ÉNALAPRIL (ENALAPRIL COMPOSITIONS)
Brazil	112018068960	formulações de enalapril
World Intellectual Property Organization (WIPO)	2014055667
Spain	2770403

Enalapril maleate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Enalapril Maleate

Introduction to Enalapril Maleate

Enalapril maleate, an angiotensin-converting enzyme (ACE) inhibitor, is widely used in the treatment of hypertension, congestive heart failure, and to prevent myocardial infarction. Here, we delve into the market dynamics and financial trajectory of this crucial pharmaceutical.

Market Size and Growth Projections

The global Enalapril Maleate market is poised for significant growth over the next few years. According to market research, the market size is expected to expand at a compound annual growth rate (CAGR) of 6.20% from 2024 to 2031, reaching substantial revenue in USD million[4].

Historical and Forecast Periods

The historical period for market analysis spans from 2019 to 2023, with 2023 serving as the base year. The forecast period extends from 2024 to 2031, during which the market is anticipated to witness robust growth driven by various factors[4].

Key Drivers of Market Growth

Rising Prevalence of Cardiovascular Diseases

The increasing prevalence of cardiovascular diseases, including hypertension and congestive heart failure, is a primary driver of the Enalapril Maleate market. As populations age and lifestyle-related health issues rise, the demand for effective treatments like enalapril is expected to surge[4].

Cost-Effectiveness

Enalapril has been shown to be cost-effective in managing congestive heart failure. A study indicated that enalapril therapy can reduce healthcare costs by $170 to $250 over a four-year period due to reduced hospitalizations[2].

Geographical Market Dynamics

• North America: Currently dominates the Enalapril Maleate market, driven by the growing prevalence of high blood pressure and cardiovascular diseases. The region is expected to continue its significant growth during the projected period[4].
• Asia-Pacific: This region is anticipated to experience the highest CAGR, driven by rising hypertension rates and improving healthcare access. Growing awareness of cardiovascular health and a shift towards preventive care are key factors[4].
• Europe: Expected to grow at a CAGR of 4.7% from 2024 to 2031, with countries like the UK showing a higher growth rate of 5.5%[4].
• Latin America and Middle East & Africa: These regions, though smaller in market share, are also expected to grow, with CAGRs of 5.6% and 5.9%, respectively[4].

Market Segmentation

The Enalapril Maleate market is segmented based on:

Type

• Capsule
• Pill[1]

Application

• Treatment of Essential Hypertension
• Treatment of Heart Failure
• Prevention of Myocardial Infarction
• Others[1]

Geography

• North America
• Europe
• Asia-Pacific
• South America
• Middle East and Africa[1]

Competitive Landscape

The market is characterized by a competitive landscape with several key players:

• Chenxin Pharmaceutical Co. Ltd.
• Zhejiang Yixin Pharmaceutical Co. Ltd.
• Jiangsu Kangyuan Pharmaceutical Co. Ltd.
• China Resources Shuanghe Limin Pharmaceutical (Jinan) Co. Ltd.
• Hebei Dongfeng Pharmaceutical Co. Ltd.
• CSPC Ouyi Pharmaceutical Co. Ltd.
• Taro Pharmaceuticals USA Inc
• Dexcel Pharma
• Accord Healthcare[1]

These companies are involved in various market-related activities such as new product launches, collaborations, mergers, and acquisitions, which contribute to the dynamic nature of the market.

Market Opportunities and Challenges

Opportunities

• Growing Demand for Cardiovascular Treatments: The increasing incidence of cardiovascular diseases presents a significant opportunity for the growth of the Enalapril Maleate market.
• Expanding Healthcare Access: Improving healthcare infrastructure and access, especially in the Asia-Pacific region, is expected to boost market growth[4].

Challenges

• Side Effects and Adverse Reactions: Enalapril can cause side effects such as hyperkalemia, dizziness, and kidney problems, which may deter some patients and affect market growth[5].
• Regulatory Hurdles: Strict regulatory environments and the need for continuous clinical trials to ensure safety and efficacy can pose challenges to market expansion.

Financial Impact and Cost-Effectiveness

Enalapril maleate is not only clinically effective but also financially beneficial. Here are some key financial aspects:

Cost Savings

• Enalapril therapy has been shown to reduce healthcare costs by reducing hospitalizations. A study estimated that enalapril can save $170 to $250 over a four-year period for congestive heart failure patients[2].

Market Revenue

• The global Enalapril Maleate market is projected to reach significant revenue in USD million by 2031, driven by its widespread use in treating hypertension and heart failure[4].

Market Outlook and Trends

Emerging Trends

• Shift Towards Preventive Care: There is a growing trend towards preventive care and early diagnosis, which is driving the demand for enalapril as a key treatment option[4].
• Increasing Awareness of Cardiovascular Health: Greater awareness among populations about cardiovascular health is leading to more diagnoses and treatments, thereby boosting the market[4].

Porter's 5 Forces Framework

• The market analysis includes a detailed examination using Porter's 5 Forces Framework, which helps in understanding the competitive intensity, bargaining power of suppliers and buyers, threat of new entrants, and the threat of substitute products[1].

Key Takeaways

• The Enalapril Maleate market is expected to grow significantly due to the rising prevalence of cardiovascular diseases.
• The market is driven by cost-effectiveness, expanding healthcare access, and a shift towards preventive care.
• Key players are actively involved in market-related activities to maintain their competitive edge.
• Despite challenges such as side effects and regulatory hurdles, the market outlook remains positive.

FAQs

What is Enalapril Maleate used for?

Enalapril maleate is used to treat high blood pressure (hypertension), congestive heart failure, and to prevent myocardial infarction[5].

What are the key drivers of the Enalapril Maleate market?

The key drivers include the rising prevalence of cardiovascular diseases, cost-effectiveness, and expanding healthcare access[4].

Which regions dominate the Enalapril Maleate market?

North America currently dominates the market, but the Asia-Pacific region is expected to grow at the highest CAGR[4].

What are the potential side effects of Enalapril Maleate?

Common side effects include dizziness, hyperkalemia, and kidney problems. Less common side effects can include chest pain, cough, and fainting[5].

How cost-effective is Enalapril Maleate?

Enalapril therapy can reduce healthcare costs by $170 to $250 over a four-year period due to reduced hospitalizations for congestive heart failure patients[2].

Sources

1. Market Research Intellect: Global Enalapril Maleate Market Size, Trends and Projections.
2. PubMed: A cost-effectiveness analysis of enalapril maleate in the management of congestive heart failure.
3. Stats and Data: Global Enalapril Maleate Market Business Opportunities 2024-2031.
4. Cognitive Market Research: Global Enalapril Market Report 2024.
5. Mayo Clinic: Enalapril (oral route) - Description.