ALISKIREN HEMIFUMARATE - Generic Drug Details

What are the generic sources for aliskiren hemifumarate and what is the scope of patent protection?

Aliskiren hemifumarate is the generic ingredient in six branded drugs marketed by Noden Pharma, Endo Operations, and Novartis, and is included in seven NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Aliskiren hemifumarate has forty patent family members in twenty-two countries.

There are four drug master file entries for aliskiren hemifumarate. Four suppliers are listed for this compound.

Summary for ALISKIREN HEMIFUMARATE

International Patents:	40
US Patents:	4
Tradenames:	6
Applicants:	3
NDAs:	7
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	63
Patent Applications:	215
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALISKIREN HEMIFUMARATE
What excipients (inactive ingredients) are in ALISKIREN HEMIFUMARATE?	ALISKIREN HEMIFUMARATE excipients list
DailyMed Link:	ALISKIREN HEMIFUMARATE at DailyMed

Pharmacology for ALISKIREN HEMIFUMARATE

Drug Class	Renin Inhibitor
Mechanism of Action	Renin Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ALISKIREN HEMIFUMARATE

C09XA	Renin-inhibitors
C09X	OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

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
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008		DISCN	Yes	No			Y
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-005	Dec 21, 2010		DISCN	No	No
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-001	Mar 5, 2007	AB	RX	Yes	No					Y

Expired US Patents for ALISKIREN HEMIFUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-001	Mar 5, 2007
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-002	Mar 5, 2007

International Patents for ALISKIREN HEMIFUMARATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2283826	Formulations galéniques de composés organiques (GALENIC FORMULATIONS OF ORGANIC COMPOUNDS)
Australia	2009202069	Galenic formulations of organic compounds
South Korea	101274855

Supplementary Protection Certificates for ALISKIREN HEMIFUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0678503	C00678503/02	Switzerland		PRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008
0678503	07C0055	France		PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
1602370	SPC/GB09/024	United Kingdom		PRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4

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