VASOTEC Drug Patent Profile

When do Vasotec patents expire, and what generic alternatives are available?

Vasotec is a drug marketed by Biovail Labs Intl and Bausch and is included in two NDAs.

The generic ingredient in VASOTEC is enalapril maleate. There are twenty-seven drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the enalapril maleate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vasotec

A generic version of VASOTEC was approved as enalapril maleate by HERITAGE PHARMA on August 22^nd, 2000.

Summary for VASOTEC

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	8
Patent Applications:	3,247
Drug Prices:	Drug price information for VASOTEC
What excipients (inactive ingredients) are in VASOTEC?	VASOTEC excipients list
DailyMed Link:	VASOTEC at DailyMed

See drug prices for VASOTEC

See drug sales revenues for VASOTEC

Recent Clinical Trials for VASOTEC

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

Sponsor	Phase
University of Wisconsin, Madison	Phase 4
Novartis Pharmaceuticals	Phase 4
Brigham and Women's Hospital	Phase 4

See all VASOTEC clinical trials

Pharmacology for VASOTEC

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

US Patents and Regulatory Information for VASOTEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biovail Labs Intl	VASOTEC	enalaprilat	INJECTABLE;INJECTION	019309-001	Feb 9, 1988		DISCN	Yes	No
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-002	Dec 24, 1985	AB	RX	Yes	No
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-005	Jul 26, 1988	AB	RX	Yes	No

Expired US Patents for VASOTEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-003	Dec 24, 1985	4,374,829*PED
Biovail Labs Intl	VASOTEC	enalaprilat	INJECTABLE;INJECTION	019309-001	Feb 9, 1988	4,374,829*PED
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-002	Dec 24, 1985	4,374,829*PED

EU/EMA Drug Approvals for VASOTEC

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 VASOTEC

See the table below for patents covering VASOTEC around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1275349	DERIVES D'ACIDE AMINIQUE (AMINO ACID DERIVATIVES)
Zimbabwe	24479	AMINO ACID DERIVATIVES AS ANTIHYPERTENSIVES
Slovenia	7913000	PROCESS FOR OBTAINING DERIVATIVES OF CARBOXYALKYLDIPEPTIDES

VASOTEC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ACE Inhibitors: A Focus on VASOTEC

Introduction

ACE (Angiotensin-Converting Enzyme) inhibitors are a class of medications widely used to treat hypertension, coronary artery disease, heart failure, and other cardiovascular conditions. One of the prominent drugs in this category is VASOTEC, also known as enalapril. This article will delve into the market dynamics and financial trajectory of ACE inhibitors, with a specific focus on VASOTEC.

Global ACE Inhibitors Market Overview

The global ACE inhibitors market is projected to experience significant growth, driven by the increasing prevalence of cardiovascular diseases and hypertension. The market is expected to reach $11,831.7 million by 2030, growing at a CAGR of 5.6% from 2023 to 2030[1][4].

Key Drivers of the ACE Inhibitors Market

Several factors are driving the growth of the ACE inhibitors market:

• Increasing Prevalence of Hypertension: According to the World Health Organization, approximately 1.28 billion adults worldwide suffer from hypertension, with a significant increase over the past 30 years[4].
• Aging Population and Lifestyle Changes: The aging population and lifestyle changes leading to hypertension are contributing to the demand for effective treatments.
• Advancements in Drug Formulations: Continuous research and development aimed at enhancing the efficacy and safety profiles of ACE inhibitors are propelling market growth[1].

Market Segmentation and Regional Insights

The ACE inhibitors market is segmented by region, with North America being the largest market in 2022. However, the Asia-Pacific region is expected to be the fastest-growing region during the forecast period due to its large population and increasing awareness of cardiovascular health[1][4].

VASOTEC (Enalapril) - A Prominent ACE Inhibitor

VASOTEC, or enalapril, is one of the frequently prescribed ACE inhibitors. It is used to treat hypertension, heart failure, and other cardiovascular conditions by relaxing the veins and arteries to reduce blood pressure.

Mechanism of Action

VASOTEC works by inhibiting the angiotensin-converting enzyme, which is responsible for converting angiotensin I to angiotensin II, a potent vasoconstrictor. By blocking this conversion, VASOTEC reduces blood pressure and alleviates symptoms associated with heart failure and other cardiovascular diseases[4].

Clinical Use and Benefits

VASOTEC is often prescribed as a first-line treatment for hypertension due to its efficacy and safety profile. It is also used in combination with other medications to manage heart failure and reduce the risk of cardiovascular events.

Financial Trajectory of ACE Inhibitors

The financial performance of the ACE inhibitors market, including drugs like VASOTEC, is influenced by several factors:

Revenue Projections

The global ACE inhibitors market is expected to grow from $6.57 billion in 2022 to $8.45 billion by 2027, at a CAGR of 5.2%[4].

Impact of Patent Expiry

The expiry of patents for branded ACE inhibitors can significantly impact their financial trajectory. When a patent expires, generic versions of the drug can enter the market, leading to a rapid erosion of brand revenues. However, the rate of this erosion can vary depending on the complexity of the drug formulation and the number of generic entrants[3].

Example: Post-Patent Expiry Dynamics

For instance, drugs like Prozac and Intal showed different patterns of brand revenue erosion post-patent expiry. While Prozac saw a rapid decline due to multiple generic entrants, Intal maintained a higher market share due to its complex non-oral formulation and fewer generic competitors. This dynamic can influence the financial strategy of pharmaceutical companies, including those producing VASOTEC[3].

Competitive Landscape

The ACE inhibitors market is highly competitive, with key players such as Novartis AG, Pfizer Inc., Merck & Co., AstraZeneca, and Sanofi focusing on strategic collaborations, product innovations, and geographical expansion to gain a competitive edge[1].

Product Innovations

Companies are investing in research and development to enhance the efficacy and safety of ACE inhibitors. Product innovations, such as new formulations and combination therapies, are a key trend in the market, helping companies to maintain market share and drive growth[4].

Challenges and Restraints

Despite the growth potential, the ACE inhibitors market faces several challenges:

• Generic Competition: The entry of generic versions of branded ACE inhibitors can lead to significant market share erosion and reduced revenues.
• Regulatory and Economic Factors: Economic sanctions, supply chain disruptions, and regulatory changes can impact the market's growth trajectory[1][4].

Recent Developments and Partnerships

Pharmaceutical companies are engaging in various strategic activities to maintain their market position. This includes acquisitions, agreements, collaborations, and partnerships aimed at expanding their product portfolios and geographical reach[1].

Financial Performance of Key Players

While specific financial data for VASOTEC is not readily available, the overall financial performance of companies in the ACE inhibitors market can provide insights. For example, Vaso Corporation, although not directly related to VASOTEC, reported a record annual revenue of $81.0 million in 2023, highlighting the potential for growth in the healthcare sector through strategic investments and product development[5].

Key Takeaways

• The global ACE inhibitors market is expected to grow significantly due to the increasing prevalence of hypertension and cardiovascular diseases.
• VASOTEC (enalapril) is a prominent ACE inhibitor with a strong clinical use and benefits profile.
• The financial trajectory of ACE inhibitors is influenced by patent expiry, generic competition, and product innovations.
• Companies are focusing on strategic collaborations and product development to maintain market share.

FAQs

What are ACE inhibitors used for?

ACE inhibitors are used to treat and manage hypertension, heart failure, coronary artery disease, diabetes, chronic kidney diseases, and other cardiovascular conditions.

How does VASOTEC (enalapril) work?

VASOTEC works by inhibiting the angiotensin-converting enzyme, reducing the production of angiotensin II, which constricts blood vessels and raises blood pressure.

What is the projected growth of the ACE inhibitors market?

The global ACE inhibitors market is projected to reach $11,831.7 million by 2030, growing at a CAGR of 5.6% from 2023 to 2030.

How does patent expiry affect the financial trajectory of ACE inhibitors?

Patent expiry can lead to the entry of generic versions, causing a rapid erosion of brand revenues. However, the rate of erosion varies depending on the drug's formulation and the number of generic entrants.

Which regions are expected to drive the growth of the ACE inhibitors market?

North America is currently the largest market, but the Asia-Pacific region is expected to be the fastest-growing region during the forecast period.

Sources

1. Coherent Market Insights: Angiotensin Converting Enzymes (ACE) Inhibitors Market
2. Vaso Corporation: Vaso Corporation Announces Financial Results for First Quarter 2024
3. Analysis Group: Beyond Lifecycle Management – Optimizing Performance Following Patent Expiry
4. GlobeNewswire: ACE Inhibitors Global Market Report 2023
5. Vaso Corporation: Vaso Corporation Announces Financial Results for Fourth Quarter and Full Year of 2023