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Last Updated: December 28, 2024

AMLODIPINE BESYLATE AND VALSARTAN Drug Patent Profile


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

Amlodipine Besylate And Valsartan is a drug marketed by Alembic, Aurobindo Pharma, Hetero Labs, Lupin, Macleods Pharms Ltd, Mylan, Novel Labs Inc, Strides Pharma, Teva Pharms Usa, and Torrent. and is included in ten NDAs.

The generic ingredient in AMLODIPINE BESYLATE AND VALSARTAN is amlodipine besylate; valsartan. There are fifty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the amlodipine besylate; valsartan profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Amlodipine Besylate And Valsartan

A generic version of AMLODIPINE BESYLATE AND VALSARTAN was approved as amlodipine besylate; valsartan by STRIDES PHARMA on March 28th, 2013.

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  • What is the 5 year forecast for AMLODIPINE BESYLATE AND VALSARTAN?
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Summary for AMLODIPINE BESYLATE AND VALSARTAN
Drug patent expirations by year for AMLODIPINE BESYLATE AND VALSARTAN
Recent Clinical Trials for AMLODIPINE BESYLATE AND VALSARTAN

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

SponsorPhase
Alphacait, LLCPhase 2
Haining Health-Coming Biotech Co., Ltd.Phase 2
CJ HealthCare CorporationPhase 1

See all AMLODIPINE BESYLATE AND VALSARTAN clinical trials

US Patents and Regulatory Information for AMLODIPINE BESYLATE AND VALSARTAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Strides Pharma AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 090011-004 Mar 28, 2013 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novel Labs Inc AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 202829-004 Mar 30, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 091235-001 Mar 30, 2015 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Strides Pharma AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 090011-001 Mar 28, 2013 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alembic AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 202713-001 Apr 3, 2015 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 VALSARTAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amlodipine Besylate and Valsartan

Introduction

Amlodipine besylate and Valsartan are two critical medications used in the treatment of hypertension and other cardiovascular conditions. The market dynamics for these drugs are influenced by a variety of factors, including demand, supply constraints, regulatory changes, and economic conditions.

Rising Demand for Amlodipine Besylate and Valsartan

The demand for Amlodipine besylate and Valsartan has been on the rise due to several key factors. The increasing prevalence of hypertension and cardiovascular diseases, particularly among aging populations and those with sedentary lifestyles, has driven up the need for these medications[3][4].

Impact of Hypertension and Cardiovascular Diseases

Hypertension is a major risk factor for cardiovascular diseases, which are among the leading causes of death globally. As populations age and adopt less healthy lifestyles, the incidence of hypertension has increased, thereby boosting the demand for antihypertensive medications like Amlodipine besylate and Valsartan[3].

Combination Therapies

The use of combination therapies, which often include both Amlodipine besylate and Valsartan, has also contributed to the increased demand. These combination therapies are preferred for their enhanced efficacy in managing hypertension and other heart conditions[5].

Supply Constraints and Price Surge

Global Supply Chain Issues

Supply constraints have played a significant role in the recent price surge of Valsartan. Dwindling product supplies across various markets, exacerbated by supply chain disruptions and stringent regulatory oversight, have constrained the production capacity of generic drug manufacturers. This has led to a shortage crisis, particularly highlighted in the USA by the American Society of Health-System Pharmacists (ASHP)[1].

Regulatory Changes

Regulatory actions, such as those implemented by the National Pharmaceutical Pricing Authority (NPPA) in India, have also impacted pricing dynamics. Starting April 1, 2024, new pricing guidelines led pharmaceutical companies to adjust their pricing strategies, contributing to an overall escalation in medication costs, including Valsartan[1].

Economic and Market Factors

Economic Recovery and Consumer Spending

The economic recovery in regions like the Eurozone, led by Germany, has increased consumer spending willingness, driving up demand for commodities like Valsartan. This economic growth, coupled with improving healthcare infrastructure and increased healthcare spending, has further fueled the market for these medications[1].

Manufacturing and Production Costs

In China, the ongoing industrial recovery and sustained manufacturing growth have led to consistent demand for pharmaceuticals. However, escalating domestic production costs and tightened supply conditions have prompted manufacturers to adjust Valsartan prices to ensure profitability[1].

Market Size and Growth Projections

Amlodipine Besylate Market

The global Amlodipine besylate market was estimated at USD 1,867.0 million in 2023 and is projected to reach USD 2,539.5 million by 2031, growing at a CAGR of 3.98% from 2024 to 2031. This growth is driven by the rising prevalence of hypertension, increasing adoption of combination therapies, and advancements in pharmaceutical formulations[3].

Regional Analysis

North America holds a significant share of the Amlodipine besylate market, driven by the high prevalence of hypertension and cardiovascular diseases, advanced healthcare infrastructure, and robust R&D activities. The Asia Pacific region is also poised for rapid growth due to increasing awareness about cardiovascular health and government initiatives promoting preventive healthcare[3].

Competitive Landscape

Market Players and Strategies

The Amlodipine besylate market is characterized by a robust competitive landscape with numerous global and regional pharmaceutical companies. Companies are investing in marketing strategies to differentiate their branded products from generic competitors, expanding online sales channels, and strengthening collaborations with healthcare providers to highlight the clinical benefits of their products[3].

Generic Competition

The ongoing patent expirations of major brands have fostered the availability of cost-effective generics, intensifying competition and broadening patient access to these essential medications. This competition is expected to continue, driving innovation and pricing strategies in the market[3].

Financial Trajectory

Price Trends

The prices of Valsartan have surged globally due to rising demand and supply constraints. It is anticipated that these prices will continue their upward trajectory in the forthcoming months, driven by sustained demand from end-consumers and potential economic stimuli such as rate cuts by central banks in developed economies[1].

Revenue Growth

The revenue growth for Amlodipine besylate is expected to be steady, with the market growing at a CAGR of 3.98% from 2024 to 2031. This growth will be supported by increasing sales through various channels, including hospital pharmacies, drug stores, and online retails, which are set to witness significant growth due to the convenience and accessibility they offer[3].

Key Takeaways

  • Rising Demand: The demand for Amlodipine besylate and Valsartan is driven by the increasing prevalence of hypertension and cardiovascular diseases.
  • Supply Constraints: Global supply chain issues and regulatory changes have led to price surges for Valsartan.
  • Economic Factors: Economic recovery and increased consumer spending have fueled the market for these medications.
  • Market Growth: The Amlodipine besylate market is projected to grow at a CAGR of 3.98% from 2024 to 2031.
  • Competitive Landscape: The market is highly competitive with numerous global and regional pharmaceutical companies vying for market share.

FAQs

What are the primary factors driving the demand for Amlodipine besylate and Valsartan?

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

How have supply constraints impacted the prices of Valsartan?

Supply constraints, exacerbated by supply chain disruptions and regulatory oversight, have led to a shortage crisis and subsequent price surges for Valsartan.

What is the projected market size for Amlodipine besylate by 2031?

The global Amlodipine besylate market is projected to reach USD 2,539.5 million by 2031.

Which regions are expected to see significant growth in the Amlodipine besylate market?

North America and the Asia Pacific region are expected to see significant growth due to high prevalence of hypertension, advanced healthcare infrastructure, and government initiatives promoting preventive healthcare.

How are pharmaceutical companies responding to the competitive landscape in the Amlodipine besylate market?

Companies are investing in marketing strategies, expanding online sales channels, and strengthening collaborations with healthcare providers to differentiate their products and maintain market share.

Sources

  1. ChemAnalyst: Valsartan Prices Surge Globally, Driven by Rising Demand and Supply Constraints.
  2. MedCraveOnline: Development and Validation of Stability Indicating HPLC Method for the Simultaneous Analysis of Amlodipine, Hydrochlorothiazide, and Valsartan in Pharmaceutical Formulation.
  3. Kings Research: Amlodipine Besylate Market Size & Share Forecast [2031].
  4. BioSpace: Amlodipine Besylate Market Size, Industry Statistics, Growth Potentials, Trends, Company Profile, Global Expansion Strategies by Top Key Vendors till 2027.
  5. NPS MedicineWise: Amlodipine/Valsartan Novartis.

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