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Last Updated: December 22, 2024

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM Drug Patent Profile


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When do Amlodipine Besylate And Atorvastatin Calcium patents expire, and when can generic versions of Amlodipine Besylate And Atorvastatin Calcium launch?

Amlodipine Besylate And Atorvastatin Calcium is a drug marketed by Apotex, Dr Reddys, Mylan, and Zydus Pharms. and is included in four NDAs.

The generic ingredient in AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM is amlodipine besylate; atorvastatin calcium. There are fifty drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the amlodipine besylate; atorvastatin calcium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Amlodipine Besylate And Atorvastatin Calcium

A generic version of AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM was approved as amlodipine besylate; atorvastatin calcium by MYLAN on November 29th, 2013.

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Summary for AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
US Patents:0
Applicants:4
NDAs:4
Finished Product Suppliers / Packagers: 6
Clinical Trials: 3
What excipients (inactive ingredients) are in AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM?AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM excipients list
DailyMed Link:AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM at DailyMed
Drug patent expirations by year for AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Recent Clinical Trials for AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

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

SponsorPhase
Alphacait, LLCPhase 2
Haining Health-Coming Biotech Co., Ltd.Phase 2
Dr. Reddy's Laboratories LimitedPhase 1

See all AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM clinical trials

US Patents and Regulatory Information for AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 207762-011 Jan 11, 2019 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 207762-002 Jan 11, 2019 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 200465-009 Nov 29, 2013 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 207762-003 Jan 11, 2019 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 200465-010 Nov 29, 2013 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apotex AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 205199-001 Nov 18, 2019 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 203874-010 Mar 7, 2014 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 ATORVASTATIN CALCIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amlodipine Besylate and Atorvastatin Calcium

Introduction

Amlodipine besylate and atorvastatin calcium are two medications often combined to treat hypertension and manage cardiovascular risk. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this combined therapy.

Market Size and Growth

The global market for amlodipine besylate is substantial and growing. As of 2022, the market was valued at USD 350 million and is expected to grow at a CAGR of 4.5% from 2023 to 2030[1]. In a broader context, the amlodipine besylate market is estimated to reach USD 2.539 billion by 2031, growing at a CAGR of 3.98% from 2024 to 2031[3].

Driving Factors

Several factors are driving the growth of the amlodipine besylate and atorvastatin calcium market:

Increasing Prevalence of Hypertension and Cardiovascular Diseases

The rising prevalence of hypertension and cardiovascular diseases globally is a significant driver. According to the WHO, approximately 1.28 million adults in low and middle-income countries suffer from hypertension, with many unaware of their condition[3].

Combination Therapies

The combination of amlodipine besylate and atorvastatin calcium has been shown to reduce cardiovascular events in hypertensive patients, making it a preferred treatment option. This combination therapy improves patient compliance and reduces prescription costs[2].

Regulatory Approvals and Endorsements

Regulatory approvals and endorsements by health organizations play a crucial role in market expansion. For instance, the single-pill formulation of amlodipine and atorvastatin has been approved in parts of Europe, enhancing its market presence[2].

Lifestyle Factors

Increased consumption of alcohol and tobacco, which are risk factors for hypertension, also contribute to market growth. The sedentary lifestyle and inadequate dietary habits of modern populations further exacerbate the demand for these medications[3][4].

Regional Analysis

North America

North America holds a significant share of the amlodipine besylate market, driven by the high prevalence of hypertension and cardiovascular diseases. Advanced healthcare infrastructure, high healthcare spending, and widespread insurance coverage ensure broad access to these medications. The region's strong regulatory framework and focus on early diagnosis and effective disease management also contribute to its leading position[3][4].

Asia-Pacific

The Asia-Pacific region is expected to witness rapid growth, with a CAGR of 5.09% over the forecast period. This is due to increasing awareness about cardiovascular health, government initiatives promoting preventive healthcare, and the rising prevalence of hypertension in the region[3].

Europe

Europe is also experiencing growth, driven by an aging population and a high incidence of chronic illnesses like hypertension. The number of patients willing to take medication to prevent or control disease increases with age, contributing to the overall demand for amlodipine besylate[4].

Market Segmentation

By Form

The market is segmented into tablets, capsules, and liquid forms. The liquid form, such as Norliqva, an oral liquid solution of amlodipine besylate, is particularly beneficial for patients who have difficulty swallowing tablets[1].

By Sales Channel

The market is classified into hospital pharmacies, drug store & pharmacies, online retails, and others. The online retail segment is set to witness significant growth due to the increasing adoption of e-commerce platforms for purchasing medications, driven by convenience and accessibility[3].

Competitive Landscape

The amlodipine besylate market is characterized by 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[4].

Financial Trajectory

The financial trajectory of the amlodipine besylate market is promising:

  • The market is estimated to reach USD 2.539 billion by 2031, growing at a CAGR of 3.98% from 2024 to 2031[3].
  • Another forecast indicates the market will reach USD 0.56 billion by 2032, at a CAGR of 5.00% during the forecast period[4].

Challenges

Despite the growth, the market faces challenges such as fierce competition from generic drugs, which leads to price erosion and reduced profit margins for manufacturers. To overcome this, pharmaceutical companies need to focus on differentiating their products through improved formulations, such as extended-release versions or combination therapies[3].

Combination Therapy Benefits

The combination of amlodipine besylate and atorvastatin calcium offers several benefits:

  • Reduced Cardiovascular Events: This combination has been demonstrated to reduce cardiovascular events in hypertensive patients with high cardiovascular risk[2].
  • Improved Patient Compliance: The single-pill formulation improves patient compliance and decreases prescription costs[2].
  • Safety Profile: The combination exhibits a safety profile consistent with its parent compounds[2].
"Amlodipine combined with atorvastatin has been demonstrated to reduce cardiovascular events in hypertensive patients at high cardiovascular risk, and the single-pill formulation has the potential to improve adherence and decrease prescription costs."[2]

Key Takeaways

  • The amlodipine besylate market is driven by the increasing prevalence of hypertension and cardiovascular diseases.
  • Combination therapies with atorvastatin enhance patient compliance and reduce cardiovascular events.
  • North America and the Asia-Pacific region are key markets due to high prevalence rates and advanced healthcare infrastructure.
  • The market faces challenges from generic competition but is expected to grow significantly over the forecast period.

FAQs

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

The amlodipine besylate market was valued at USD 350 million in 2022 and is estimated to reach USD 2.539 billion by 2031[1][3].

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

The primary drivers include the increasing prevalence of hypertension and cardiovascular diseases, combination therapies, regulatory approvals, and lifestyle factors such as increased alcohol and tobacco consumption[3][4].

Q3: Which region is expected to witness the fastest growth in the amlodipine besylate market?

The Asia-Pacific region is expected to witness the fastest growth, driven by increasing awareness about cardiovascular health and government initiatives promoting preventive healthcare[3].

Q4: What are the benefits of the combination therapy of amlodipine besylate and atorvastatin calcium?

The combination therapy reduces cardiovascular events, improves patient compliance, and decreases prescription costs. It also exhibits a safety profile consistent with its parent compounds[2].

Q5: Who are the key players in the amlodipine besylate market?

Key players include Pfizer, Mylan, Reddy’s Laboratories, Apotex, Teva Pharmaceutical, Cipla, Hikma Pharmaceuticals, Strides Pharma, Upsher-Smith Laboratories, and InvaGen Pharmaceuticals[4].

Sources

  1. UnivDatos: Global Amlodipine Besylate Market Current Analysis and Forecast (2023-2030)[1].
  2. PubMed: A single-pill combination of amlodipine besylate and atorvastatin[2].
  3. Kings Research: Amlodipine Besylate Market Size & Share Forecast [2031][3].
  4. Market Research Future: Amlodipine Besylate Market Trends, Growth, Forecast 2032[4].

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