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Last Updated: December 22, 2024

ALISKIREN HEMIFUMARATE Drug Patent Profile


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Which patents cover Aliskiren Hemifumarate, and when can generic versions of Aliskiren Hemifumarate launch?

Aliskiren Hemifumarate is a drug marketed by Endo Operations and is included in one NDA.

The generic ingredient in ALISKIREN HEMIFUMARATE is aliskiren hemifumarate. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the aliskiren hemifumarate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Aliskiren Hemifumarate

A generic version of ALISKIREN HEMIFUMARATE was approved as aliskiren hemifumarate by ENDO OPERATIONS on March 22nd, 2019.

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Drug patent expirations by year for ALISKIREN HEMIFUMARATE
Pharmacology for ALISKIREN HEMIFUMARATE
Drug ClassRenin Inhibitor
Mechanism of ActionRenin Inhibitors
Paragraph IV (Patent) Challenges for ALISKIREN HEMIFUMARATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TEKTURNA Tablets aliskiren hemifumarate 150 mg and 300 mg 021985 1 2014-01-27

US Patents and Regulatory Information for ALISKIREN HEMIFUMARATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Operations ALISKIREN HEMIFUMARATE aliskiren hemifumarate TABLET;ORAL 206665-001 Mar 22, 2019 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Endo Operations ALISKIREN HEMIFUMARATE aliskiren hemifumarate TABLET;ORAL 206665-002 Mar 22, 2019 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

ALISKIREN HEMIFUMARATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aliskiren Hemifumarate

Introduction to Aliskiren Hemifumarate

Aliskiren hemifumarate, marketed as Tekturna and Rasilez, is a renin inhibitor that interferes with the renin-angiotensin system (RAS), a critical pathway in the regulation of blood pressure. Approved by the US FDA in March 2007 and in Europe in August 2007, aliskiren is primarily used for the treatment of hypertension[2].

Market Size and Growth

The global aliskiren market is experiencing moderate growth, driven by several key factors. The market size is estimated to grow significantly over the forecast period, primarily due to the increasing effectiveness of aliskiren in controlling hypertension. Aliskiren can be combined with all classes of current antihypertensive drugs, which increases the number of patients achieving blood pressure control[3].

Drivers of Market Growth

Increasing Effectiveness in Hypertension Control

Aliskiren's ability to effectively reduce blood pressure has been demonstrated in several clinical trials. Its compatibility with other antihypertensive drugs enhances its utility, making it a preferred option for patients with hypertension[3].

Government Initiatives and Health Awareness

Government initiatives and a rise in health awareness are significant drivers of the market. As more people become aware of the importance of managing hypertension, the demand for effective treatments like aliskiren increases[3].

Demand for Personalized Medicines

The growing demand for personalized medicines and better diagnostic facilities also propels the market forward. Aliskiren's role in treating hypertensive diabetic patients is a major driver, as it offers a targeted approach to managing complex conditions[3].

Challenges and Restraints

High Cost of Components

One of the major restraints on the market is the high cost of the components used in aliskiren medicines. This cost can limit accessibility, especially in regions with lower healthcare budgets[3].

Production Constraints

Production constraints, including poor absorption from the gastrointestinal tract, low bioavailability, and a short half-life, also hinder the market growth. These pharmacokinetic issues can affect the drug's efficacy and patient compliance[3].

Market Segmentation

By Type

The aliskiren market is segmented into 150 mg tablets, 300 mg tablets, and other formulations. These different dosages cater to various patient needs and treatment plans[3].

By Application

The market is segmented by application into hospitals, drug stores, and other healthcare settings. Hospitals and drug stores are the primary distribution channels for aliskiren[3].

By Geography

Geographically, the market is divided into North America, Europe, Asia Pacific, and the rest of the world. North America is expected to grow at the highest CAGR during the forecast period due to the presence of major players and a well-developed healthcare infrastructure[3].

Competitive Landscape

The global aliskiren market is competitive, with several key players contributing to its growth. Major players include:

  • Noden Pharma
  • LGM Pharma
  • Cayman
  • Vitae-GSK
  • Daiichi Sankyo
  • Novartis
  • Merck-Frost
  • Mitsubishi-Tanabe
  • Takeda
  • Cadila Healthcare

These companies are involved in various strategies such as partnerships, collaborations, and agreements to enhance their market share and product offerings[3].

Financial Performance and Market Ranking

The financial performance of these companies is a critical indicator of the market's overall health. Key development strategies, market share, and market ranking analysis are essential for understanding the competitive dynamics. Companies like Novartis and Daiichi Sankyo have significant financial resources and a strong global presence, which helps them maintain a leading position in the market[3].

Clinical Trials and Future Prospects

Aliskiren has shown promising results in clinical trials beyond its primary use in hypertension. Trials have indicated beneficial effects in conditions such as heart failure and diabetic nephropathy, suggesting potential future indications for the drug[2].

"Recent and ongoing clinical trials regarding heart failure and diabetic nephropathy demonstrated first beneficial effects of aliskiren in these conditions (reduction of urinary albumin/creatinine-ratio and NTproBNP, respectively)"[2].

Key Takeaways

  • The global aliskiren market is growing moderately, driven by its effectiveness in controlling hypertension and compatibility with other antihypertensive drugs.
  • Government initiatives and increasing health awareness are significant drivers.
  • High costs and production constraints are major restraints.
  • The market is segmented by type, application, and geography, with North America expected to grow at the highest CAGR.
  • Major players are engaged in various strategies to enhance their market share.

FAQs

1. What is the primary use of aliskiren hemifumarate?

Aliskiren hemifumarate is primarily used for the treatment of hypertension.

2. Which region is expected to grow at the highest CAGR in the aliskiren market?

North America is expected to grow at the highest CAGR during the forecast period.

3. What are the major drivers of the aliskiren market?

The major drivers include increasing effectiveness in controlling hypertension, compatibility with other antihypertensive drugs, government initiatives, and rising health awareness.

4. What are the significant restraints on the aliskiren market?

High costs of components and production constraints such as poor absorption and low bioavailability are significant restraints.

5. Which companies are major players in the aliskiren market?

Major players include Noden Pharma, LGM Pharma, Cayman, Vitae-GSK, Daiichi Sankyo, Novartis, Merck-Frost, Mitsubishi-Tanabe, Takeda, and Cadila Healthcare.

Cited Sources:

  1. Datam Intelligence - Renin-Inhibitors Market Size, Share, Industry, Forecast and outlook (2023-2030)
  2. PubMed - Aliskiren hemifumarate
  3. Verified Market Research - Aliskiren Market Size, Share, Scope, Trends, Opportunities & Forecast
  4. Valuates Reports - Aliskiren Hemifumarate - Global Market Insights and Sales Trends
  5. Synapse - Aliskiren Fumarate - Drug Targets, Indications, Patents

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