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Last Updated: December 22, 2024

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE Drug Patent Profile


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When do Amlodipine Besylate And Benazepril Hydrochloride patents expire, and what generic alternatives are available?

Amlodipine Besylate And Benazepril Hydrochloride is a drug marketed by Amneal, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Norvium Bioscience, Strides Pharma, Teva Pharms, Watson Labs, and Watson Labs Inc. and is included in twelve NDAs.

The generic ingredient in AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE is amlodipine besylate; benazepril hydrochloride. There are fifty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; benazepril hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Amlodipine Besylate And Benazepril Hydrochloride

A generic version of AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE was approved as amlodipine besylate; benazepril hydrochloride by LUPIN PHARMS on February 5th, 2010.

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Summary for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
US Patents:0
Applicants:10
NDAs:12
Finished Product Suppliers / Packagers: 14
Raw Ingredient (Bulk) Api Vendors: 2
Clinical Trials: 6
Patent Applications: 12
What excipients (inactive ingredients) are in AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE?AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE excipients list
DailyMed Link:AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE at DailyMed
Drug patent expirations by year for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Recent Clinical Trials for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

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

SponsorPhase
Shanghai Jiao Tong University School of MedicinePhase 4
Novartis PharmaceuticalsPhase 4
Dr. Reddy's Laboratories LimitedPhase 1

See all AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE clinical trials

US Patents and Regulatory Information for AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 077179-001 May 18, 2007 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Norvium Bioscience AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 079047-001 Jul 5, 2011 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 077890-003 Oct 14, 2010 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

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amlodipine Besylate and Benazepril Hydrochloride

Introduction to Amlodipine Besylate and Benazepril Hydrochloride

Amlodipine besylate and benazepril hydrochloride, often combined in medications like Lotrel, are crucial in the management of hypertension and cardiovascular diseases. Amlodipine besylate is a calcium channel blocker, while benazepril hydrochloride is an angiotensin-converting enzyme (ACE) inhibitor. Together, they provide a synergistic effect in reducing blood pressure and alleviating symptoms of heart diseases.

Global Market Size and Growth

The global market for amlodipine besylate, a key component of these combination therapies, has been experiencing steady growth. As of 2023, the market size was recorded at USD 1,867.0 million, with projections indicating it will reach USD 1,933.0 million in 2024 and USD 2,539.5 million by 2031, growing at a compound annual growth rate (CAGR) of 3.98% from 2024 to 2031[2][3].

Driving Factors for Market Growth

Rising Prevalence of Hypertension and Cardiovascular Diseases

The increasing prevalence of hypertension and cardiovascular diseases globally is a significant driver of the market. According to the World Health Organization (WHO), approximately 1.28 million adults aged 30-79 in low and middle-income countries suffer from hypertension, with many remaining unaware of their condition[2].

Increasing Adoption of Combination Therapies

The market is also fueled by the increasing adoption of combination therapies that include amlodipine besylate. These combinations enhance patient compliance and accessibility, contributing to the sustained demand for this medication[2][3].

Advancements in Pharmaceutical Formulations

Advancements in pharmaceutical formulations, such as extended-release versions, are crucial in differentiating products and maintaining market competitiveness. These improved formulations help in better disease management and patient adherence[2].

Regional Analysis

North America

North America dominates the global amlodipine besylate market, with a market share of around 34.56% in 2023. This dominance is attributed to the high prevalence of hypertension and cardiovascular diseases, advanced healthcare infrastructure, high healthcare spending, and widespread insurance coverage in the region[2][3].

Asia Pacific

The Asia Pacific region is poised for rapid growth, registering a CAGR of 5.09% during the forecast period. This growth is driven by increasing awareness about cardiovascular health, rising prevalence of hypertension, and government initiatives promoting preventive healthcare and early treatment[2][3].

Competitive Landscape

The amlodipine besylate market features a robust competitive landscape with numerous global and regional pharmaceutical companies. Key players include Pfizer, Mylan, Reddy’s Laboratories, Apotex, Teva Pharmaceutical, Cipla, Hikma Pharmaceuticals, Strides Pharma, Upsher-Smith Laboratories, and InvaGen Pharmaceuticals[2].

Challenges and Opportunities

Fierce Competition from Generic Drugs

The market faces significant competition from generic drugs, leading to price erosion and reduced profit margins for manufacturers. To overcome this, pharmaceutical companies must focus on differentiating their products through improved formulations and combination therapies[2].

Increasing Demand and Supply Dynamics

The demand for amlodipine besylate is continuously growing, but it is often met with supply challenges. For instance, global prices surged in March 2024 due to peak demand and dwindling supplies, particularly post-Chinese New Year when manufacturing slows down in China[2].

Pharmacoeconomic Impact

A study on the pharmacoeconomic impact of amlodipine besylate in Italy highlighted its cost-effectiveness in treating coronary artery disease (CAD). The study showed that adding amlodipine besylate to standard care reduced major vascular events and revascularization procedures, resulting in significant savings in hospital expenditures[2].

Market Projections and Forecast

The global amlodipine besylate market is expected to continue its upward trajectory, driven by the increasing prevalence of cardiovascular diseases, advancements in pharmaceutical formulations, and the growing adoption of online retail channels. By 2032, the market is projected to reach USD 0.56 billion at a CAGR of 5.00% during the forecast period[2].

Role of Online Retail

The online retail segment is expected to witness significant growth at a CAGR of 4.67% from 2024 to 2031, driven by the convenience and accessibility offered by e-commerce platforms. The COVID-19 pandemic has accelerated the shift toward online purchasing, highlighting the importance of this sales channel in ensuring continuous access to essential medications including amlodipine besylate[3].

Combination Therapies: Amlodipine Besylate and Benazepril Hydrochloride

Combination therapies like Lotrel, which combine amlodipine besylate and benazepril hydrochloride, are gaining traction due to their synergistic effects. These combinations are formulated in various strengths for oral administration and are designed to achieve steady-state levels after about a week of once-daily dosing[5].

Key Takeaways

  • The global amlodipine besylate market is growing steadily, driven by the rising prevalence of hypertension and cardiovascular diseases.
  • The market is segmented by form and sales channel, with online retail expected to see significant growth.
  • North America and the Asia Pacific region are key markets, with the latter experiencing rapid growth.
  • The competitive landscape is robust, with major pharmaceutical companies competing for market share.
  • Lifestyle factors and digital health initiatives are influencing market dynamics.
  • The market is projected to reach USD 2,539.5 million by 2031 and USD 0.56 billion by 2032.

FAQs

Q1: What is the current market size of the amlodipine besylate market?

The global amlodipine besylate market size was recorded at USD 1,867.0 million in 2023[2].

Q2: What are the primary drivers of the amlodipine besylate market growth?

The primary drivers include the rising prevalence of hypertension and cardiovascular diseases, increasing adoption of combination therapies, and advancements in pharmaceutical formulations[2].

Q3: Which region dominates the global amlodipine besylate market?

North America dominates the global amlodipine besylate market, with a market share of around 34.56% in 2023[2].

Q4: How is the online retail segment impacting the amlodipine besylate market?

The online retail segment is expected to witness significant growth at a CAGR of 4.67% from 2024 to 2031, driven by the convenience and accessibility offered by e-commerce platforms[3].

Q5: What is the pharmacoeconomic impact of amlodipine besylate in treating cardiovascular diseases?

A study in Italy highlighted that adding amlodipine besylate to standard care reduced major vascular events and revascularization procedures, resulting in significant savings in hospital expenditures[2].

Citations

  1. Market Research Future: Amlodipine Besylate Market Size, Share & Forecast Report 2032[1].
  2. Drug Patent Watch: Generic AMLODIPINE BESYLATE INN equivalents, drug patent[2].
  3. Kings Research: Amlodipine Besylate Market Size & Share Forecast [2031][3].
  4. ChemAnalyst: Amlodipine Besylate Market Size, Share, Growth & Forecast[4].
  5. FDA: Lotrel (amlodipine besylate and benazepril hydrochloride) Label[5].

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