Enalaprilat - Generic Drug Details

What are the generic drug sources for enalaprilat and what is the scope of freedom to operate?

Enalaprilat is the generic ingredient in two branded drugs marketed by Chartwell Injectable, Dr Reddys, Hikma Farmaceutica, Hospira, and Biovail Labs Intl, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for enalaprilat. Three suppliers are listed for this compound.

Summary for enalaprilat

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	7
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	11
Patent Applications:	5,046
What excipients (inactive ingredients) are in enalaprilat?	enalaprilat excipients list
DailyMed Link:	enalaprilat at DailyMed

Recent Clinical Trials for enalaprilat

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

Sponsor	Phase
University of Maryland, Baltimore	Phase 4
University of Guadalajara	Phase 2
Ethicare GmbH	Phase 2/Phase 3

See all enalaprilat clinical trials

Pharmacology for enalaprilat

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

Medical Subject Heading (MeSH) Categories for enalaprilat

Angiotensin-Converting Enzyme Inhibitors

Antihypertensive Agents

US Patents and Regulatory Information for enalaprilat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	ENALAPRILAT	enalaprilat	INJECTABLE;INJECTION	075456-001	Aug 22, 2000		DISCN	No	No
Hospira	ENALAPRILAT	enalaprilat	INJECTABLE;INJECTION	075458-001	Aug 22, 2000	AP	RX	No	No
Chartwell Injectable	ENALAPRILAT	enalaprilat	INJECTABLE;INJECTION	075634-001	Aug 22, 2000	AP	RX	No	No
Biovail Labs Intl	VASOTEC	enalaprilat	INJECTABLE;INJECTION	019309-001	Feb 9, 1988		DISCN	Yes	No
Hikma Farmaceutica	ENALAPRILAT	enalaprilat	INJECTABLE;INJECTION	078687-001	Dec 23, 2008	AP	RX	No	Yes

Expired US Patents for enalaprilat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Biovail Labs Intl	VASOTEC	enalaprilat	INJECTABLE;INJECTION	019309-001	Feb 9, 1988

Enalaprilat Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Enalaprilat

Introduction to Enalaprilat

Enalaprilat, the active metabolite of enalapril, is a crucial medication in the treatment of hypertension and heart failure. It belongs to the class of ACE inhibitors, which play a vital role in relaxing blood vessels, reducing blood pressure, and alleviating the strain on the heart.

Global Market Size and Growth Projections

The global enalaprilat market is poised for significant growth in the coming years. According to market research, the global enalaprilat market size in 2023 was estimated to be in the millions, and it is expected to expand at a compound annual growth rate (CAGR) from 2024 to 2031[4].

Regional Market Analysis

North America

North America dominates the ACE inhibitors market, including enalaprilat, due to the high prevalence of cardiovascular diseases such as hypertension and heart failure. The region's market is driven by an aging population and increasing awareness of hypertension risks, which contributes to better diagnosis and treatment access[3].

Asia-Pacific

The Asia-Pacific region is expected to experience the highest CAGR during the forecast period. This growth is attributed to rising hypertension rates and improving healthcare access. The increasing awareness of cardiovascular health and a shift towards preventive care and early diagnosis are key drivers for the demand of enalaprilat in this region[1].

Europe

Europe also holds a significant share of the global enalaprilat market. The region's growth is fueled by the rising incidence of cardiovascular diseases and the availability of less expensive conventional alternatives. Countries like the United Kingdom are expected to see a CAGR of 5.5% from 2024 to 2031[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa regions, though smaller in market share, are also expected to grow. Latin America is projected to grow at a CAGR of 5.6%, while the Middle East & Africa region is expected to grow at a CAGR of 5.9% from 2024 to 2031[1].

Market Drivers

Rising Prevalence of Cardiovascular Diseases

The increasing prevalence of cardiovascular diseases such as hypertension and heart failure is a major driver for the enalaprilat market. By 2030, it is estimated that more than 8 million people in the United States will have heart failure, significantly impacting the demand for ACE inhibitors like enalaprilat[5].

Aging Population

The aging population in many regions, particularly in North America and Europe, contributes to the growing demand for enalaprilat. Older adults are more prone to cardiovascular diseases, which necessitates the use of ACE inhibitors for management and treatment[3].

Improving Healthcare Infrastructure

Advancements in healthcare infrastructure and better diagnostic tools have improved the detection and treatment of cardiovascular diseases. This has led to an increased demand for effective treatments like enalaprilat[3].

Market Restraints

Patent Expirations and Generic Competition

The expiration of patents for enalapril and enalaprilat has led to the entry of generic competitors, which can reduce the market share of branded products. However, this also makes the medication more accessible and affordable, potentially increasing overall market size[2].

Regulatory Challenges

Regulatory hurdles and the need for continuous compliance with changing healthcare regulations can pose challenges to the growth of the enalaprilat market. Companies must navigate these complexities to maintain their market position[4].

Competitive Landscape

The enalaprilat market is competitive, with several key players focusing on strengthening their product portfolios and expanding their business globally. Companies like Hikma Pharmaceuticals and Novartis Hexal AG are prominent in this market, continuously working on strategy building models to maintain their market share[4].

Financial Trajectory

Revenue Projections

The global enalaprilat market is expected to see significant revenue growth from 2024 to 2031, driven by the increasing demand for ACE inhibitors. The market size is projected to expand at a CAGR of around 6-8%, depending on the region and market dynamics[1][4].

Sales and Market Share

North America currently dominates the market, but the Asia-Pacific region is expected to make significant gains due to its high CAGR. The market share distribution among regions will continue to shift as healthcare access and awareness improve globally[1].

Technological and Regulatory Trends

Patent Analysis

The patent landscape for enalaprilat is complex, with numerous patents and patent applications. Understanding these patents is crucial for companies to avoid litigation and ensure compliance. For instance, there are several international and US patents related to enalapril maleate, which is closely related to enalaprilat[2].

Clinical Trials and Research

Continuous research and clinical trials are essential for the development and approval of new formulations and indications for enalaprilat. These trials help in understanding the efficacy and safety of the drug, which can lead to expanded market opportunities[2].

Market Attractiveness and SWOT Analysis

Market Attractiveness

The enalaprilat market is attractive due to its growing demand driven by the increasing prevalence of cardiovascular diseases. The market's potential for expansion, especially in regions with improving healthcare infrastructure, makes it a lucrative segment for pharmaceutical companies[4].

SWOT Analysis

• Strengths: Established efficacy, wide acceptance as a treatment for hypertension and heart failure, and a strong presence of key players.
• Weaknesses: Generic competition, regulatory challenges, and potential side effects.
• Opportunities: Growing demand in emerging markets, advancements in healthcare infrastructure, and the potential for new indications.
• Threats: Patent expirations, regulatory changes, and competition from other classes of antihypertensive drugs[4].

Key Takeaways

• The global enalaprilat market is expected to grow significantly from 2024 to 2031, driven by the rising prevalence of cardiovascular diseases.
• North America currently dominates the market, but the Asia-Pacific region is expected to experience the highest CAGR.
• Improving healthcare infrastructure and an aging population are key drivers for the market.
• The competitive landscape is marked by the presence of several key players and the impact of generic competition.
• Continuous research and compliance with regulatory requirements are essential for market growth.

FAQs

What is the expected CAGR of the global enalaprilat market from 2024 to 2031?

The global enalaprilat market is expected to expand at a CAGR of around 6-8% from 2024 to 2031[1][4].

Which region is expected to have the highest CAGR for the enalaprilat market?

The Asia-Pacific region is expected to have the highest CAGR for the enalaprilat market during the forecast period[1].

What are the key drivers for the enalaprilat market?

The key drivers include the rising prevalence of cardiovascular diseases, an aging population, and improvements in healthcare infrastructure[1][3][5].

Who are the major players in the enalaprilat market?

Major players include Hikma Pharmaceuticals and Novartis Hexal AG, among others[4].

How does generic competition affect the enalaprilat market?

Generic competition can reduce the market share of branded products but also makes the medication more accessible and affordable, potentially increasing overall market size[2].

Sources

1. Cognitive Market Research: Global Enalapril Market Report 2024.
2. DrugPatentWatch: Enalapril maleate - Generic Drug Details.
3. TechSci Research: North America ACE Inhibitors Market By Size, Share and Forecast.
4. Cognitive Market Research: Global Enalaprilat Market Report 2024 Edition.
5. Journal of the American College of Cardiology: 2019 ACC Expert Consensus Decision Pathway on Risk Assessment, Prevention, and Early Recognition and Management of Heart Failure.