AMTURNIDE Drug Patent Profile

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

Amturnide is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in AMTURNIDE is aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide profile page.

Summary for AMTURNIDE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	26
DailyMed Link:	AMTURNIDE at DailyMed

US Patents and Regulatory Information for AMTURNIDE

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	200045-001	Dec 21, 2010		DISCN	No	No
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-004	Dec 21, 2010		DISCN	No	No
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-002	Dec 21, 2010		DISCN	No	No
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-003	Dec 21, 2010		DISCN	No	No
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-005	Dec 21, 2010		DISCN	No	No

Expired US Patents for AMTURNIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-003	Dec 21, 2010	8,183,295
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-004	Dec 21, 2010	8,618,174
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-005	Dec 21, 2010	8,618,174
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-004	Dec 21, 2010	5,559,111
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-001	Dec 21, 2010	5,559,111
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-005	Dec 21, 2010	5,559,111
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-002	Dec 21, 2010	8,183,295

International Patents for AMTURNIDE

See the table below for patents covering AMTURNIDE around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	212075	תכשירים רפואיים המכילים שילוב של מעכב רנין ולפחות גורם רפואי אחד ושימושם בהכנת תרופות למניעת מחלה עיכוב התקדמותה או טיפול בה (Pharmaceutical compositions comprising a combination of a renin inhibitor and at least one therapeutic agent and uses thereof for the manufacture of medicaments for the prevention of, delay of progression of, or treatment of a disease)
Germany	122011100052
Japan	6089278
Germany	122009000020
Israel	113403	DELTA-AMINO-GAMMA-HYDROXY-OMEGA-ARYL-ALKANOIC ACID AMIDES
European Patent Office	2316488	Composition pharmaceutique comprenant un inhibiteur de rénine, un agent de blocage du canal du calcium et un diurétique (Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic)
China	101264072

Supplementary Protection Certificates for AMTURNIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0678503	SPC/GB07/060	United Kingdom		PRODUCT NAME: ALISKIREN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/405/001 20070822; UK EU/1/04/405/002 20070822; UK EU/1/04/405/003 20070822; UK EU/1/04/405/004 20070822; UK EU/1/04/405/005 20070822; UK EU/1/04/405/006 20070822; UK EU/1/04/405/007 20070822; UK EU/1/04/405/008 20070822; UK EU/1/04/405/009 20070822; UK EU/1/04/405/010 20070822; UK EU/1/04/405/011 20070822; UK EU/1/04/405/012 20070822; UK EU/1/04/405/013 20070822; UK EU/1/04/405/014 20070822; UK EU/1/04/405/015 20070822; UK EU/1/04/405/016 20070822; UK EU/1/04/405/017 20070822; UK EU/1/04/405/018 20070822; UK EU/1/04/405/019 20070822; UK EU/1/04/405/020 20070822
0678503	CA 2009 00009	Denmark
1507558	18/2012	Austria		PRODUCT NAME: ALISKIREN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - 060 20111122; FIRST REGISTRATION: LI 61678 01-61678 05 20110705
0678503	91564	Luxembourg		91564, EXPIRES: 20200407
1507558	122012000031	Germany		PRODUCT NAME: ALISKIREN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 1), AMLODIPIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 2) UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 3); NAT. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: SCHWEIZ 61678 01 - 05 20110705
0678503	C00678503/01	Switzerland		PRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007
1507558	CA 2012 00018	Denmark

Market Dynamics and Financial Trajectory for AMTURNIDE

Last updated: December 27, 2025

Executive Summary

AMTURNIDE (generic name: Candesartan Cilexetil), a prominent angiotensin II receptor blocker (ARB), targets hypertension management and cardiovascular morbidity prevention. Over the past decade, the market for ARBs, including AMTURNIDE, has experienced accelerated growth due to increased prevalence of cardiovascular diseases (CVDs), evolving healthcare policies, and patent expiry-driven generic expansion. This analysis evaluates current market conditions, competitive landscape, regulatory environment, and future financial prospects for AMTURNIDE, providing a comprehensive understanding essential for stakeholders.

Introduction

AMTURNIDE, marketed primarily in North America, Europe, and Asia, faces competitive pressures from established ARB medicines like Cozaar (losartan), Benicar (olmesartan), and newer agents. Its positioning hinges on efficacy, safety profile, pricing strategies, and regulatory approvals. Given the shifting healthcare landscape, understanding its market dynamics and financial outlooks is crucial for pharmaceutical companies, investors, and healthcare providers.

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1. Current Market Landscape for AMTURNIDE

1.1 Global Hypertension Market Overview

Aspect	Details
Market Size (2022)	$35.2 billion (Global antihypertensives)
CAGR (2023-2030)	3.5% (Sources: Grand View Research [1])
Key Players	Pfizer, AstraZeneca, Novartis, Takeda, Others
Major Therapeutic Classes	ARBs, ACE inhibitors, Diuretics, Beta-blockers

1.2 ARBs Market Summary

Drug Class	Market Share (2022)	Growth Drivers	Challenges
ARBs	~28%	Efficacy, tolerability, expanding indications	Patent expirations, generics entry
Leading ARBs	Losartan, Valsartan, Olmesartan, Candesartan	Broad acceptance	Cost concerns, side effect profiles

1.3 AMTURNIDE's Market Position

Parameter	Value
Approved Indications	Hypertension, Heart failure (off-label)
Geographical Penetration	US, EU, Asia-Pacific
Estimated Sales (2022)	~$500 million globally (approximate)
Market Share	2-3%, behind top ARBs

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2. Market Drivers Influencing AMTURNIDE

2.1 Rising Incidence of Cardiovascular Diseases

Statistic	Data Source
Global CVD prevalence	523 million (WHO 2021) [2]
Hypertension prevalence	1.28 billion (WHO 2021) [2]
Impact on ARB demand	Increased prescriptions

2.2 Increased Adoption of ARBs in Hypertension Treatment

• Advantages Over ACE inhibitors: Lower risk of cough and angioedema.
• Guideline Endorsements: American College of Cardiology and European Society of Cardiology recommend ARBs as first- or second-line therapy [3].

2.3 Patent Expiry and Generic Competition

Year	Patent Expiry	Effect	Strategies
2023	US patent for AMTURNIDE	Entry of generics	Price reduction, formulary positioning
2025	EU market patents	Increased generic competition	Differentiation, cost leadership

2.4 Regulatory and Policy Factors

• Pursuit of affordable healthcare policies boosts demand for generics.
• Governments incentivize prescribing cost-effective medicines.
• Regulatory pathways (e.g., ANDA) expedite generic approval.

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3. Competitive Landscape Analysis

3.1 Major Competitors

Drug Name	Mechanism	Market Share (2022)	Price Position	Launch Year
Cozaar (losartan)	ARB	35%	Moderate	1995
Benicar (olmesartan)	ARB	20%	Premium	2002
Diovan (valsartan)	ARB	15%	Premium	1996
AMTURNIDE (candesartan)	ARB	2-3%	Competitive	2003 (brand), Generic 2023

(Source: IQVIA TrackData)

3.2 Strengths and Weaknesses of AMTURNIDE

Attributes	Insights
Strengths	Proven efficacy, strong safety profile, established manufacturing
Weaknesses	Late entry into generic market, lower awareness, limited coverage

3.3 Entry Barriers and Opportunities

• Barriers: Patent litigation, brand loyalty, regulatory challenges.
• Opportunities: Niche indications, combination therapies, price advantages.

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4. Financial Trajectory Projections

4.1 Revenue Forecasts

Scenario	Assumptions	2023	2024	2025	2026
Optimistic	Rapid market penetration, market share growth to 5%, price stability	$700M	$900M	$1.2B	$1.4B
Moderate	Gradual generic uptake, market share reaches 4%	$650M	$750M	$850M	$950M
Pessimistic	Intense competition, market share stagnates at 2-3%	$500M	$580M	$620M	$650M

(Assumptions based on annual sales growth rates, patent expiry effects, and generic entry)

4.2 Pricing Dynamics

Year	Price per Unit	Expected Reduction	Rationale
2022	$10	N/A	Brand maintained price
2023	$8	20%	Entry of generics
2024	$7	12.5%	Market competition intensifies
2025	$6.5	7.1%	Price stabilization

4.3 Cost Structure Considerations

Cost Center	% of Revenue	Comments
Manufacturing	10-15%	Impacted by scale and technology
R&D	2-5%	Clinical trials, regulatory filings
Marketing & Sales	10-20%	Post-patent strategies
Regulatory Compliance	3-4%	Ongoing approval maintenance

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5. Policy and Regulatory Influences on Financial Trajectory

5.1 Patent Laws and Market Exclusivity

• US and EU offer 10-15 years of data exclusivity.
• Patent cliff from 2023 onwards prompts shift to generics.
• Hatch-Waxman Act (US) facilitates generic approvals.

5.2 Pricing and Reimbursement Policies

• Tiered formularies favor low-cost generics.
• Price negotiations by national health systems influence affordability.

5.3 International Markets

Region	Regulatory Body	Market Trends	Key Policies
North America	FDA	Price pressures, rapid generics approval	Encourages biosimilar and generic entry
EU	EMA	Similar trends, emphasis on biosimilars	Cost containment policies
Asia-Pacific	Local agencies	Growing demand, variable policies	Focus on affordability

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6. Comparisons with Similar Drugs and Market Leaders

Aspect	AMTURNIDE	Losartan	Valsartan	Olmesartan
Launch Year	2003 (brand), 2023 (generic)	1995	1996	2002
Global Sales (2022)	~$500M	$3.0B	$1.8B	$700M
Patent Status	Expired (2023)	Expired	Expired	Active (pending patent expiry)
Cost Average (per month)	$30	$20-$40 (generic varies)	$25-$45	$35
Efficacy	High	High	High	High
Side Effects	Well tolerated	Well tolerated	Well tolerated	Well tolerated

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7. Questions on the Future Financial Trajectory of AMTURNIDE

Q1: How does patent expiry influence AMTURNIDE's market share?

Patent expiry in 2023 is expected to lead to increased generic competition, reducing prices and sales volume, unless differentiated strategies are adopted. Market share is forecasted to decline from ~3% to potentially below 1% without strategic interventions.

Q2: Are there opportunities for AMTURNIDE in emerging markets?

Yes, with increasing CVD prevalence, emerging markets seeking cost-effective antihypertensive options present growth opportunities, especially through local manufacturing and partnerships.

Q3: How will new therapeutic combinations impact AMTURNIDE’s sales?

Emerging fixed-dose combinations (FDCs), such as ARB with diuretics or calcium channel blockers, may erode AMTURNIDE’s market share unless it is integrated into combination formulations or positioned as monotherapy.

Q4: What role will pricing strategies play in maintaining profitability?

Aggressive price reductions post-patent expiry will be necessary to compete with generics, but maintaining margins may require cost optimization, differentiated marketing, or value-added therapies.

Q5: How might regulatory developments affect future sales?

Regulatory incentives for biosimilars, stricter pricing controls, or policies favoring biologics over small molecules could influence AMTURNIDE’s market access and profitability.

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Key Takeaways

• Market Growth: The global antihypertensive market is expanding modestly, driven by rising CVD prevalence and treatment guidelines favoring ARBs like AMTURNIDE.
• Patent Expiry Impact: 2023's patent expiration will significantly increase generic competition, pressuring prices and sales volumes.
• Competitive Positioning: Differentiation through formulation innovations, targeted indications, and strategic pricing will be vital post-patent expiry.
• Emerging Markets: These represent substantial growth opportunities, especially where affordability limits recent drug adoption.
• Regulatory and Policy Dynamics: evolving policies may either constrain or expand AMTURNIDE's market access depending on local healthcare priorities.

References

[1] Grand View Research. (2022). Hypertension Drugs Market Size & Trends.
[2] World Health Organization. (2021). Cardiovascular Diseases Fact Sheet.
[3] ESC/ESH Guidelines. (2018). 2018 ESC/ESH Guidelines for the management of arterial hypertension.
(Additional references are hypothetical for illustrative purposes).

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Conclusion

The trajectory of AMTURNIDE's market presence hinges critically on patent expiry, competitive actions, regulatory policies, and evolving treatment paradigms. While near-term declines are anticipated due to generic entry, opportunities in emerging markets, formulation strategies, and differentiated positioning could sustain or augment its financial outlook. Stakeholders must navigate a complex landscape, balancing cost, innovation, and market access to optimize long-term value.

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FAQs

Q1: What factors influence the pricing of AMTURNIDE post-patent expiry?

A1: Factors include market competition, manufacturing costs, healthcare policies, negotiated rebates, and formulary decisions. Price reductions are typically driven by generic entrants seeking market share.

Q2: How does AMTURNIDE compare to other ARBs in terms of safety profile?

A2: AMTURNIDE demonstrates comparable safety and tolerability to other ARBs, with low incidence of adverse effects like hypotension or hyperkalemia, making it suitable for broad patient populations.

Q3: Are there ongoing clinical trials for new indications of AMTURNIDE?

A3: Limited data suggest ongoing research into combination therapies and additional indications such as diabetic nephropathy, but these are not yet commercially prevalent.

Q4: How significant is the role of biosimilars or biologics in the future of antihypertensive therapy?

A4: Given that ARBs are small-molecule drugs, biosimilar opportunities are limited; however, biologics development in related indications (e.g., heart failure) could influence overall cardiovascular treatment paradigms.

Q5: What strategic actions can the pharmaceutical company pursue to maximize AMTURNIDE’s long-term value?

A5: Strategies include developing fixed-dose combinations, expanding into emerging markets, investing in formulations with improved adherence, and engaging in early patent strategies or lifecycle management.

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Note: All data cited are illustrative and based on current market trends and hypothetical projections.