ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - Generic Drug Details

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

Aliskiren hemifumarate; amlodipine besylate is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Aliskiren hemifumarate; amlodipine besylate has twenty-three patent family members in twenty-one countries.

Summary for ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

International Patents:	23
US Patents:	1
Tradenames:	2
Applicants:	1
NDAs:	2
DailyMed Link:	ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Constraining patent/regulatory exclusivity:

8,613,949

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Anatomical Therapeutic Chemical (ATC) Classes for ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

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

US Patents and Regulatory Information for ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-004	Aug 26, 2010		DISCN	No	No	8,613,949		Y
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-001	Dec 21, 2010		DISCN	No	No
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-001	Aug 26, 2010		DISCN	No	No	8,613,949		Y
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-003	Dec 21, 2010		DISCN	No	No

Expired US Patents for ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-001	Aug 26, 2010	5,559,111
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-004	Aug 26, 2010	5,559,111
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-003	Aug 26, 2010	5,559,111
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-002	Aug 26, 2010	5,559,111

International Patents for ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Country	Patent Number	Title	Estimated Expiration
Morocco	32719	تركيبات خاصة بصناعة الأدوية من مركبات عضوية
South Korea	20110060942	FIXED DOSE COMBINATION IN FORM OF BILAYERED OR MONOLAYERED TABLET OF ALISKIREN AND AMLODIPINE
Brazil	PI0919350	combinação de dose fixa oral farmacêutica na forma de uma comprimido monocamada, bem como seu uso e seu método de preparação
Tunisia	2011000100	GALENICAL FORMULATIONS OF ORGANIC COMPOUNDS

Supplementary Protection Certificates for ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

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
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aliskiren Hemifumarate and Amlodipine Besylate

Introduction to Aliskiren Hemifumarate and Amlodipine Besylate

Aliskiren hemifumarate and amlodipine besylate are two significant medications in the cardiovascular disease treatment landscape. Aliskiren hemifumarate is a direct renin inhibitor used primarily to treat hypertension, while amlodipine besylate is a calcium channel blocker used to manage hypertension and angina.

Market Dynamics of Aliskiren Hemifumarate

Market Size and Growth

The aliskiren hemifumarate market has experienced substantial growth and is projected to continue this trend. 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[1][4].

Drivers

• Increasing Prevalence of Hypertension: The rising global incidence of hypertension is a key driver for the aliskiren hemifumarate market. As more people are diagnosed with hypertension, the demand for effective antihypertensive medications increases.
• Advancements in Pharmaceutical Formulations: Improvements in drug formulations that enhance patient compliance and accessibility are driving market growth.
• Regulatory Approvals: Positive regulatory environments and endorsements by health organizations support the market expansion[1].

Restraints

• Competition from Generics: The availability of generic versions of aliskiren hemifumarate can lead to price erosion and reduced profit margins for manufacturers. This competition necessitates innovation in product differentiation, such as improved formulations or combination therapies[1].

Opportunities

• Growing Awareness and Early Diagnosis: Increasing awareness programs and early diagnosis initiatives for hypertension present opportunities for market growth.
• Expanding Healthcare Infrastructure: Advances in healthcare infrastructure, particularly in emerging markets, offer new avenues for the distribution and use of aliskiren hemifumarate[1].

Challenges

• Economic and Regulatory Challenges: Economic fluctuations and stringent regulatory requirements can pose challenges to the market. Manufacturers must navigate these complexities to maintain market share[1].

Market Dynamics of Amlodipine Besylate

Market Size and Growth

The global amlodipine besylate market was valued 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[2].

Drivers

• Rising Prevalence of Hypertension and Cardiovascular Diseases: The increasing incidence of hypertension and cardiovascular diseases globally drives the demand for amlodipine besylate.
• Advancements in Pharmaceutical Formulations: Improvements in drug formulations, such as extended-release versions and combination therapies, enhance patient compliance and accessibility.
• Regulatory Endorsements: Regulatory approvals and endorsements by health organizations support the market expansion[2][5].

Restraints

• Competition from Generic Drugs: The presence of generic versions of amlodipine besylate leads to price competition, reducing profit margins for branded manufacturers.
• Lifestyle Factors: While lifestyle factors like increased alcohol and tobacco consumption contribute to the market growth, they also pose a challenge in terms of managing the underlying causes of hypertension[2].

Opportunities

• Growing Awareness and Early Treatment: Increasing awareness programs and early treatment initiatives for cardiovascular diseases offer significant opportunities for market growth.
• Expanding Online Retail: The rise of online retail for pharmaceuticals provides new channels for the distribution of amlodipine besylate, enhancing accessibility and convenience for patients[2].

Challenges

• Economic and Regulatory Pressures: Economic fluctuations and stringent regulatory requirements can impact market dynamics. Manufacturers must innovate and differentiate their products to maintain market share[2].

Financial Trajectory of Aliskiren Hemifumarate

Revenue Projections

The aliskiren hemifumarate market is expected to see significant revenue growth from 2023 to 2031, driven by its various applications and geographical expansion. The market is segmented into different purity levels and applications, each contributing to the overall revenue[1][4].

Regional Analysis

• North America: This region is expected to be a major contributor due to its advanced healthcare infrastructure and high prevalence of hypertension.
• Asia-Pacific: This region is anticipated to experience rapid growth due to increasing awareness and government initiatives promoting preventive healthcare[1][4].

Financial Trajectory of Amlodipine Besylate

Revenue Projections

The amlodipine besylate market is projected to grow from USD 1,867.0 million in 2023 to USD 2,539.5 million by 2031, with a CAGR of 3.98% from 2024 to 2031. This growth is driven by the rising prevalence of hypertension and cardiovascular diseases, as well as advancements in pharmaceutical formulations[2].

Regional Analysis

• North America: This region holds the largest market share due to the high prevalence of hypertension and advanced healthcare infrastructure. The region's strong regulatory framework and focus on early diagnosis and treatment also contribute to its dominance[2][5].
• Asia-Pacific: This region is expected to witness significant growth due to increasing awareness about cardiovascular health and government initiatives promoting early treatment[2].

Key Players and Competitive Landscape

Aliskiren Hemifumarate

Key manufacturers include Ambeed, BioCrick, and other global players. These companies focus on differentiating their products through improved formulations and strategic marketing to maintain market share[4].

Amlodipine Besylate

The market is characterized by a robust competitive landscape with key players such as Pfizer, Mylan, Reddy’s Laboratories, Apotex, Teva Pharmaceutical, and others. These companies compete through innovative formulations, combination therapies, and strong distribution networks[2][5].

Impact of Digital Health Initiatives

Online Retail Growth

The COVID-19 pandemic has accelerated the shift towards online purchasing of pharmaceuticals, including both aliskiren hemifumarate and amlodipine besylate. Online retail provides patients with easy access to a wide range of medications, often at competitive prices, contributing to market growth[2].

Regulatory Environment

Approvals and Endorsements

Regulatory approvals and endorsements by health organizations play a crucial role in the market expansion of both medications. Positive regulatory environments ensure that these medications remain primary treatments for hypertension and cardiovascular diseases[1][2].

Conclusion

The markets for aliskiren hemifumarate and amlodipine besylate are poised for significant growth driven by increasing prevalence of hypertension, advancements in pharmaceutical formulations, and expanding healthcare infrastructure. While competition from generics and economic pressures pose challenges, the overall outlook remains optimistic.

Key Takeaways

• Growing Demand: Both markets are driven by the rising global incidence of hypertension and cardiovascular diseases.
• Innovative Formulations: Advancements in drug formulations are crucial for market growth and patient compliance.
• Regional Expansion: North America and Asia-Pacific are key regions for market growth due to their healthcare infrastructure and increasing awareness about cardiovascular health.
• Online Retail: The rise of online retail is enhancing accessibility and convenience for patients.
• Regulatory Support: Positive regulatory environments and endorsements by health organizations are vital for market expansion.

FAQs

What are the primary drivers for the aliskiren hemifumarate market?

The primary drivers include the increasing prevalence of hypertension, advancements in pharmaceutical formulations, and regulatory approvals.

How is the amlodipine besylate market expected to grow?

The amlodipine besylate market is projected to grow at a CAGR of 3.98% from 2024 to 2031, reaching USD 2,539.5 million by 2031.

Which region dominates the amlodipine besylate market?

North America holds the largest market share due to its advanced healthcare infrastructure and high prevalence of hypertension.

What role does online retail play in the market growth of these medications?

Online retail provides patients with easy access to medications, often at competitive prices, contributing significantly to market growth, especially post-COVID-19.

Who are the key players in the amlodipine besylate market?

Key players include Pfizer, Mylan, Reddy’s Laboratories, Apotex, Teva Pharmaceutical, and others.

Sources

1. Market Research Intellect: Aliskiren Hemifumarate Market Size, Scope And Forecast Report.
2. Kings Research: Amlodipine Besylate Market Size & Share Forecast [2031].
3. Transparency Market Research: Amlodipine Market Size, Share, Growth, Current Analysis, 2034.
4. Infinity Business Insights: Aliskiren Hemifumarate Market, Global Outlook and Forecast 2023-2029.
5. Market Research Future: Amlodipine Besylate Market Trends, Growth, Forecast 2032.