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Last Updated: December 22, 2024

DILTIAZEM MALATE; ENALAPRIL MALEATE - Generic Drug Details


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

Diltiazem malate; enalapril maleate is the generic ingredient in one branded drug marketed by Biovail and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for DILTIAZEM MALATE; ENALAPRIL MALEATE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
DailyMed Link:DILTIAZEM MALATE; ENALAPRIL MALEATE at DailyMed

US Patents and Regulatory Information for DILTIAZEM MALATE; ENALAPRIL MALEATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biovail TECZEM diltiazem malate; enalapril maleate TABLET, EXTENDED RELEASE;ORAL 020507-001 Oct 4, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for DILTIAZEM MALATE; ENALAPRIL MALEATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Biovail TECZEM diltiazem malate; enalapril maleate TABLET, EXTENDED RELEASE;ORAL 020507-001 Oct 4, 1996 4,983,598 ⤷  Subscribe
Biovail TECZEM diltiazem malate; enalapril maleate TABLET, EXTENDED RELEASE;ORAL 020507-001 Oct 4, 1996 4,374,829 ⤷  Subscribe
Biovail TECZEM diltiazem malate; enalapril maleate TABLET, EXTENDED RELEASE;ORAL 020507-001 Oct 4, 1996 4,968,507 ⤷  Subscribe
Biovail TECZEM diltiazem malate; enalapril maleate TABLET, EXTENDED RELEASE;ORAL 020507-001 Oct 4, 1996 4,880,631 ⤷  Subscribe
Biovail TECZEM diltiazem malate; enalapril maleate TABLET, EXTENDED RELEASE;ORAL 020507-001 Oct 4, 1996 4,472,380 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

DILTIAZEM MALATE; ENALAPRIL MALEATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diltiazem Malate and Enalapril Maleate

Introduction

Diltiazem malate and enalapril maleate, often combined in medications like Teczem, are crucial in the management of cardiovascular diseases. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this drug combination.

Market Size and Growth

The diltiazem market, which includes diltiazem malate, is projected to experience significant growth. In North America, the diltiazem market was valued at US$ 161.53 million in 2021 and is expected to reach US$ 369.22 million by 2028, growing at a CAGR of 12.5% from 2021 to 2028[1][3].

Key Market Drivers

Several factors are driving the growth of the diltiazem market:

Increase in Cardiovascular Disease Incidence

The rising incidence of cardiovascular diseases, such as hypertension, angina, and atrial fibrillation, is a major driver. Cardiovascular diseases are more prevalent among the elderly, and the global elderly population is increasing, contributing to the market growth[1][3].

Increasing Elderly Population

The elderly population is more prone to cardiovascular diseases due to structural and functional changes in the cardiovascular system associated with aging. This demographic shift is expected to bolster the demand for diltiazem and its combinations[1][3].

Government Initiatives and Awareness

Government initiatives to promote cardiovascular health and increase awareness about the benefits of early treatment also contribute to the market's growth[1].

Market Restraints

Despite the positive trends, there are some restraints to consider:

Side Effects of Diltiazem

The side effects associated with diltiazem, such as dizziness, headache, and potential allergic reactions, can negatively impact market growth. These side effects may lead to reduced patient compliance and alternative treatment options[1][3][4].

Product Segmentation

The diltiazem market is segmented by product type and application:

Product Type

  • Tablets: Held the largest share of the market in 2021.
  • Capsules: Expected to witness the fastest CAGR from 2021 to 2028.
  • Injection: Also a significant segment, though smaller compared to tablets and capsules[1][3].

Application

  • Hypertension: Held the largest share of the market in 2021.
  • Angina: Expected to grow at the fastest CAGR during the coming years.
  • Others: Includes applications such as atrial fibrillation and atrial flutter[1][3].

Therapeutic Areas and Mechanism of Action

Diltiazem malate is a calcium channel blocker that relaxes blood vessels, reducing the heart's workload. Enalapril maleate is an ACE inhibitor that prevents blood vessel constriction. Together, they are used to lower blood pressure and prevent and treat heart failure[4][5].

Impact of COVID-19

The COVID-19 pandemic has had a positive impact on the diltiazem market. The increased focus on healthcare and the development of vaccines and drugs have boosted the pharmaceutical industry, including the market for cardiovascular medications[1].

Key Players and Market Density

Major companies operating in the diltiazem market include Bausch Health, Teva Pharmaceutical Industries Ltd, Mylan N.V, Athenex, and Pfizer, Inc. These companies are innovating to meet evolving customer demands and maintaining their brand presence in the global market[3].

Regional Insights

The diltiazem market is analyzed across various regions, including North America, Europe, Asia Pacific, Middle East and Africa, and South and Central America. North America is a significant market due to the high prevalence of cardiovascular diseases and advanced healthcare infrastructure[3].

Future Trends and Developments

Recent developments in the market include product innovations and strategic expansions by key players. The emphasis on meeting evolving customer demands and adopting new technologies is expected to drive market growth in the coming years[3].

Financial Trajectory

The financial trajectory of the diltiazem market is promising, with a projected CAGR of 12.3% to 12.5% from 2021 to 2028. The market size is expected to more than double, indicating strong financial growth driven by increasing demand and innovative product strategies[1][3].

Key Takeaways

  • The diltiazem market is driven by the increasing incidence of cardiovascular diseases and the growing elderly population.
  • The market is segmented by product type (tablets, capsules, injection) and application (hypertension, angina, others).
  • Side effects of diltiazem are a significant restraint.
  • Key players are innovating to meet customer demands and expanding their market presence.
  • The COVID-19 pandemic has positively impacted the market.
  • The financial trajectory indicates strong growth with a CAGR of 12.3% to 12.5% from 2021 to 2028.

FAQs

What are the primary uses of diltiazem malate and enalapril maleate?

Diltiazem malate and enalapril maleate are used to lower blood pressure and to prevent and treat heart failure. They are also used for conditions such as hypertension, angina, and atrial fibrillation[4].

What are the common side effects of diltiazem and enalapril?

Common side effects include mild dizziness, headache, dry cough, flushing, insomnia, and nausea. Serious side effects can include allergic reactions, jaundice, and severe dizziness or fainting[4].

How is the diltiazem market segmented?

The market is segmented by product type (tablets, capsules, injection) and application (hypertension, angina, others)[1][3].

What is the impact of the COVID-19 pandemic on the diltiazem market?

The COVID-19 pandemic has had a positive impact on the diltiazem market, boosting the pharmaceutical industry and increasing focus on healthcare[1].

Which companies are major players in the diltiazem market?

Major companies include Bausch Health, Teva Pharmaceutical Industries Ltd, Mylan N.V, Athenex, and Pfizer, Inc.[3].

Sources:

  1. Business Market Insights: North America Diltiazem Market report 2028.
  2. Synapse: Diltiazem Malate/Enalapril Maleate - Drug Targets, Indications, Patents.
  3. The Insight Partners: Diltiazem Market Size, Share & Growth Analysis by 2028.
  4. Drugs.com: Diltiazem and enalapril Uses, Side Effects & Warnings.
  5. DrugBank Online: Diltiazem malate.

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