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

Last Updated: December 22, 2024

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide and what is the scope of freedom to operate?

Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
DailyMed Link:ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE at DailyMed

US Patents and Regulatory Information for ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-004 Dec 21, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-005 Dec 21, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-001 Dec 21, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-003 Dec 21, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis AMTURNIDE aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide TABLET;ORAL 200045-002 Dec 21, 2010 DISCN 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 ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aliskiren Hemifumarate, Amlodipine Besylate, and Hydrochlorothiazide

Introduction

Aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide are key components in various antihypertensive medications. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Overview

The global market for aliskiren hemifumarate is experiencing robust growth, driven by its effectiveness in treating hypertension. Here are some key points:

  • Growth Projections: The aliskiren hemifumarate market is anticipated to grow significantly from 2023 to 2031, with a positive trend in market dynamics indicating robust growth rates[1][3][5].
  • Market Segmentation: The market is segmented by type (97% purity, 98% purity, 99% purity) and application (pharmaceutical, health products, cosmetic, other), as well as by geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[1][3].

Drivers of Market Growth

Several factors are driving the growth of the market for these antihypertensive drugs:

  • Increasing Effectiveness: Aliskiren, when combined with other antihypertensive drugs like amlodipine and hydrochlorothiazide, shows higher rates of therapeutic response and blood pressure control compared to monotherapy[2][5].
  • Government Initiatives and Health Awareness: Increased government initiatives and rising health awareness are contributing to the growth of the market[5].
  • Combination Therapy: Aliskiren can be combined with all classes of current antihypertensive drugs, increasing the number of patients achieving blood pressure control[5].

Restraints and Challenges

Despite the growth, there are several challenges that affect the market:

  • High Production Costs: The high cost of the components of aliskiren medicines and production constraints hinder market growth[5].
  • Pharmacokinetic Issues: Poor absorption from the gastrointestinal tract, low bioavailability, and short half-life are challenges in the development of aliskiren compounds[5].

Competitive Landscape

The competitive landscape of the aliskiren market is characterized by several key players:

  • Major Players: Companies such as Novartis, Noden Pharma, LGM Pharma, Cayman, Vitae-GSK, Daiichi Sankyo, Merck-Frost, Mitsubishi-Tanabe, and Cadila Healthcare are prominent in the market[5].
  • Market Ranking and Strategies: These companies are engaged in various strategies including partnerships, collaborations, and new product launches to maintain their market share and ranking[5].

Financial Performance

The financial performance of the aliskiren hemifumarate market is promising:

  • Revenue Forecast: The market is forecasted to grow in terms of revenue throughout the prognosis period from 2023 to 2031, with significant growth rates anticipated[1][3][5].
  • Regional Analysis: The North American market is expected to grow at the highest CAGR during the forecast period due to the presence of major players and increasing adoption of these systems[5].

Product Specifics

Aliskiren Hemifumarate

  • Applications: Used in medications such as Tekturna, Tekturna HCT, Tekamlo, and Amturnide to treat hypertension[4].
  • Purity Levels: Available in 97%, 98%, and 99% purity levels, each with different market projections[1][3].

Amlodipine Besylate

  • Combination Therapy: Often combined with aliskiren to enhance therapeutic response and blood pressure control. For example, Tekamlo combines aliskiren hemifumarate and amlodipine besylate[2][4].
  • Effectiveness: Studies have shown that aliskiren/amlodipine is more effective than aliskiren/HCTZ in reducing systolic and diastolic blood pressure[2].

Hydrochlorothiazide (HCTZ)

  • Combination Therapy: Used in combination with aliskiren in medications like Tekturna HCT to treat hypertension. This combination is effective but may have different efficacy and tolerability compared to aliskiren/amlodipine[2][4].

Market Outlook

The market outlook for these drugs is optimistic:

  • Trends and Growth Catalysts: The market is influenced by trends such as the increasing demand for personalized medicines and better diagnostic facilities. Growth catalysts include the effectiveness of combination therapies and government initiatives[5].
  • Challenges and Opportunities: While high production costs and pharmacokinetic issues pose challenges, the rise in health awareness and the need for effective antihypertensive treatments present significant opportunities[5].

Porter's 5 Forces Framework

The competitive analysis using Porter's 5 Forces Framework highlights:

  • Threat of New Entrants: Moderate due to high production costs and regulatory barriers.
  • Bargaining Power of Suppliers: High due to the dependency on specific raw materials.
  • Bargaining Power of Buyers: Moderate as patients have options but are often guided by healthcare professionals.
  • Threat of Substitute Products: Low to moderate as aliskiren offers unique benefits in combination therapy.
  • Competitive Rivalry Among Existing Competitors: High due to the presence of multiple key players[1].

Macro-Economic and Value Chain Analysis

The macro-economic analysis and value chain scrutiny reveal:

  • Economic Landscapes: The market is influenced by economic conditions, healthcare policies, and demographic changes.
  • Value Chain: The value chain includes raw material suppliers, manufacturers, distributors, and healthcare providers, each playing a crucial role in the market dynamics[1].

Pricing Analysis

Pricing analysis is critical for understanding market dynamics:

  • Product Pricing: The pricing of aliskiren hemifumarate and its combination products is influenced by production costs, market demand, and competitive pricing strategies[1].

Key Takeaways

  • The aliskiren hemifumarate market is poised for significant growth driven by its effectiveness in treating hypertension.
  • Combination therapies with amlodipine and hydrochlorothiazide enhance therapeutic outcomes.
  • High production costs and pharmacokinetic issues are key challenges.
  • The market is competitive with several major players engaging in strategic partnerships and new product launches.
  • Regional markets, especially North America, are expected to see high growth rates.

FAQs

What are the primary applications of aliskiren hemifumarate?

Aliskiren hemifumarate is primarily used in pharmaceutical, health products, and to a lesser extent in cosmetic applications[1][3].

How effective is aliskiren when combined with amlodipine or hydrochlorothiazide?

Aliskiren combined with amlodipine or hydrochlorothiazide is more effective than monotherapy in controlling blood pressure, with aliskiren/amlodipine being more effective than aliskiren/HCTZ[2].

What are the key drivers of the aliskiren market growth?

Key drivers include increasing effectiveness in controlling hypertension, the ability to combine with all classes of current antihypertensive drugs, and rising health awareness and government initiatives[5].

What are the main challenges facing the aliskiren market?

High production costs, poor absorption from the gastrointestinal tract, low bioavailability, and short half-life are significant challenges[5].

Which regions are expected to see the highest growth in the aliskiren market?

The North American market is expected to grow at the highest CAGR during the forecast period due to the presence of major players and increasing adoption of these systems[5].

Sources

  1. Market Research Intellect, "Aliskiren Hemifumarate Market Size, Scope And Forecast Report", December 2024.
  2. PubMed, "Aliskiren/amlodipine vs. aliskiren/hydrochlorothiazide in hypertension", 2013.
  3. Valuates Reports, "Aliskiren Hemifumarate - Global Market Insights and Sales Trends", 2023.
  4. FDA, "Aliskiren Information", July 8, 2015.
  5. Verified Market Research, "Aliskiren Market Size, Share, Scope, Trends, Opportunities & Forecast", 2023.

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.