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Last Updated: December 22, 2024

ENALAPRIL MALEATE Drug Patent Profile


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

Enalapril Maleate is a drug marketed by 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, Cosette, Dr Reddys Labs Ltd, Nostrum Labs Inc, Rising, and Taro Pharm Inds. and is included in thirty NDAs.

The generic ingredient in ENALAPRIL MALEATE is enalapril maleate; hydrochlorothiazide. There are twenty-seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.

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Drug patent expirations by year for ENALAPRIL MALEATE
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Recent Clinical Trials for ENALAPRIL MALEATE

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SponsorPhase
Manchester University NHS Foundation TrustPhase 2
Newcastle-upon-Tyne Hospitals NHS TrustPhase 3
South Tees Hospitals NHS Foundation TrustPhase 3

See all ENALAPRIL MALEATE clinical trials

Pharmacology for ENALAPRIL MALEATE
Medical Subject Heading (MeSH) Categories for ENALAPRIL MALEATE
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
Cosette ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 075727-001 Sep 18, 2001 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075472-004 Aug 22, 2000 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ivax Sub Teva Pharms ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075482-003 Aug 22, 2000 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz Inc ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075459-002 Aug 22, 2000 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Unique Pharm ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 218531-003 Sep 19, 2024 AB RX 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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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.

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