You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

Benazepril hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for benazepril hydrochloride and what is the scope of patent protection?

Benazepril hydrochloride is the generic ingredient in four branded drugs marketed by Amneal Pharms, Ani Pharms, Aurobindo Pharma, Chartwell Rx, Corepharma, Genpharm, Heritage Pharma, Prinston Inc, Rising, Sun Pharm Inds Ltd, Teva, Zydus Lifesciences, Validus Pharms, Apotex, Aurobindo Pharma Usa, Mylan Pharms Inc, and Sandoz, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for benazepril hydrochloride. Twenty-seven suppliers are listed for this compound.

Summary for benazepril hydrochloride
US Patents:0
Tradenames:4
Applicants:17
NDAs:21
Drug Master File Entries: 14
Finished Product Suppliers / Packagers: 27
Raw Ingredient (Bulk) Api Vendors: 99
Clinical Trials: 44
Patent Applications: 3,102
What excipients (inactive ingredients) are in benazepril hydrochloride?benazepril hydrochloride excipients list
DailyMed Link:benazepril hydrochloride at DailyMed
Recent Clinical Trials for benazepril hydrochloride

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

SponsorPhase
Northwell HealthPhase 2
Lupus Research AlliancePhase 2
Shanghai Children's HospitalPhase 2

See all benazepril hydrochloride clinical trials

Pharmacology for benazepril hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for benazepril hydrochloride

US Patents and Regulatory Information for benazepril hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx BENAZEPRIL HYDROCHLORIDE benazepril hydrochloride TABLET;ORAL 076402-004 Feb 11, 2004 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan Pharms Inc BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE benazepril hydrochloride; hydrochlorothiazide TABLET;ORAL 076612-004 Feb 11, 2004 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma Usa BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE benazepril hydrochloride; hydrochlorothiazide TABLET;ORAL 076688-002 Feb 11, 2004 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan Pharms Inc BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE benazepril hydrochloride; hydrochlorothiazide TABLET;ORAL 076612-002 Feb 11, 2004 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx BENAZEPRIL HYDROCHLORIDE benazepril hydrochloride TABLET;ORAL 076402-003 Feb 11, 2004 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

Expired US Patents for benazepril hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Validus Pharms LOTENSIN benazepril hydrochloride TABLET;ORAL 019851-001 Jun 25, 1991 ⤷  Subscribe ⤷  Subscribe
Validus Pharms LOTENSIN benazepril hydrochloride TABLET;ORAL 019851-004 Jun 25, 1991 ⤷  Subscribe ⤷  Subscribe
Validus Pharms LOTENSIN benazepril hydrochloride TABLET;ORAL 019851-003 Jun 25, 1991 ⤷  Subscribe ⤷  Subscribe
Validus Pharms LOTENSIN benazepril hydrochloride TABLET;ORAL 019851-002 Jun 25, 1991 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Benazepril hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Benazepril Hydrochloride

Introduction

Benazepril hydrochloride, an angiotensin-converting enzyme (ACE) inhibitor, is a crucial medication in the management of hypertension and chronic renal disease. The market for this drug is experiencing significant growth, driven by several key factors.

Market Size and Projections

The global benazepril hydrochloride market was valued at approximately USD 100 billion in 2023 and is projected to reach USD 147.75 billion by 2031, growing at a compound annual growth rate (CAGR) of 5% from 2024 to 2031[1][4].

Key Drivers of Market Growth

Increasing Prevalence of Hypertension

The rising incidence of hypertension, which affects over 1.28 billion people worldwide according to the World Health Organization, is a primary driver of the benazepril hydrochloride market. Lifestyle factors such as poor diet, lack of exercise, and stress contribute to higher blood pressure levels, increasing the demand for antihypertensive medications like benazepril[4].

Aging Population

The global elderly population is growing, particularly in developed regions, and this demographic is more susceptible to various health issues, including hypertension and chronic renal disease. This demographic shift is expected to drive up demand for benazepril hydrochloride[1].

Advances in Pharmaceutical Research and Development

Continuous research and development efforts aimed at improving the therapeutic efficacy and safety profiles of benazepril hydrochloride are driving market expansion. Novel formulations and enhanced delivery systems are attracting more patients and healthcare providers[1].

Government Policies and Healthcare Spending

Supportive government policies that promote healthcare affordability and accessibility, along with increasing healthcare spending, are significant factors driving the growth of the benazepril hydrochloride market[1].

Geographical Market Distribution

North America

North America holds a major market share, accounting for more than 40% of the global revenue, with a market size of USD 57,562.4 million in 2024. This region is expected to grow at a CAGR of 3.7% from 2024 to 2031[4].

Europe

Europe accounts for over 30% of the global revenue, with a market size of USD 30,754.26 million in 2024. The European market is projected to grow at a CAGR of 4.0% from 2024 to 2031[4].

Asia Pacific

The Asia Pacific region holds around 23% of the global revenue, with a market size of USD 23,578.27 million in 2024. This region is expected to grow at a CAGR of 7.5% from 2024 to 2031, making it one of the fastest-growing markets[4].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa hold smaller but significant market shares, with 5% and 2% of the global revenue, respectively. These regions are expected to grow at CAGRs of 4.9% and 5.2% from 2024 to 2031[4].

Therapeutic Indications and Usage

Hypertension Management

Benazepril hydrochloride is FDA-approved for the treatment of hypertension, either as monotherapy or in combination with other antihypertensive agents. It reduces blood pressure and the risk of significant cardiovascular events such as myocardial infarctions and strokes[2].

Chronic Renal Disease

The drug is also used to treat chronic renal disease, particularly in patients with diabetes. Its ability to reduce proteinuria and slow the progression of renal disease makes it a valuable treatment option[2].

Pharmacokinetics and Pharmacodynamics

Absorption and Distribution

Benazepril's pharmacokinetics are dose-proportional within the 10 to 80 mg dosage range. The active metabolite, benazeprilat, reaches peak plasma concentrations within 1 to 2 hours after oral administration. Both benazepril and benazeprilat are highly protein-bound[2].

Metabolism and Elimination

Benazepril is almost completely metabolized in the liver to benazeprilat, with a half-life of approximately 10 to 11 hours. The drug is eliminated predominantly by renal excretion[2].

Safety and Adverse Effects

Contraindications

Benazepril is contraindicated in pregnancy due to the risk of fetal teratogenicity and death. It should also be avoided in patients with cirrhosis and ascites due to the risk of hepatorenal syndrome[2].

Common Adverse Effects

Common adverse effects include angioedema, intestinal angioedema, and hepatic failure. Patients should be closely monitored for these conditions, and the drug should be discontinued if any of these adverse effects occur[2].

Market Opportunities and Challenges

Opportunities

  • Growing Demand: The increasing prevalence of hypertension and chronic renal disease presents a significant opportunity for market growth.
  • Innovative Formulations: Continuous R&D efforts to improve therapeutic efficacy and safety profiles can attract more patients and healthcare providers.
  • Government Support: Supportive government policies and increasing healthcare spending can enhance market accessibility and affordability[1].

Challenges

  • Competition: The antihypertensive market is highly competitive, with numerous ACE inhibitors and other antihypertensive drugs available.
  • Regulatory Hurdles: Strict regulatory requirements and the need for continuous clinical trials can pose challenges for new formulations and market entry.
  • Side Effects: The risk of adverse effects such as angioedema and hepatic failure requires careful patient monitoring and management[2].

Key Takeaways

  • The global benazepril hydrochloride market is projected to grow significantly due to the increasing prevalence of hypertension and chronic renal disease.
  • Advances in pharmaceutical R&D and supportive government policies are key drivers of market growth.
  • The market is geographically diverse, with North America, Europe, and Asia Pacific being the major contributors.
  • Benazepril hydrochloride is a critical medication in hypertension management and chronic renal disease treatment, but it comes with specific safety considerations.

FAQs

What is the primary use of benazepril hydrochloride?

Benazepril hydrochloride is primarily used for the treatment of hypertension and chronic renal disease.

What are the key drivers of the benazepril hydrochloride market?

The key drivers include the increasing prevalence of hypertension, the growing elderly population, advances in pharmaceutical R&D, and supportive government policies.

What are the common adverse effects of benazepril hydrochloride?

Common adverse effects include angioedema, intestinal angioedema, and hepatic failure.

Is benazepril hydrochloride safe during pregnancy?

No, benazepril hydrochloride is contraindicated in pregnancy due to the risk of fetal teratogenicity and death.

How is benazepril hydrochloride metabolized and eliminated?

Benazepril is metabolized in the liver to its active metabolite benazeprilat and is eliminated predominantly by renal excretion.

Sources

  1. Market Research Intellect: Benazepril Hydrochloride Market Size and Projections.
  2. NCBI Bookshelf: Benazepril - StatPearls.
  3. Cognitive Market Research: Benazepril Market Report 2024 (Global Edition).
  4. Synapse: Benazepril Hydrochloride - Drug Targets, Indications, Patents.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.