Aliskiren hemifumarate; hydrochlorothiazide - Generic Drug Details

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

Aliskiren hemifumarate; hydrochlorothiazide is the generic ingredient in one branded drug marketed by Noden Pharma and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Aliskiren hemifumarate; hydrochlorothiazide has thirty-two patent family members in twenty-five countries.

Summary for aliskiren hemifumarate; hydrochlorothiazide

International Patents:	32
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aliskiren hemifumarate; hydrochlorothiazide
DailyMed Link:	aliskiren hemifumarate; hydrochlorothiazide at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for aliskiren hemifumarate; hydrochlorothiazide

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; hydrochlorothiazide

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
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

Paragraph IV (Patent) Challenges for ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TEKTURNA HCT	Tablets	aliskiren hemifumarate; hydrochlorothiazide	150 mg/12.5 mg 150 mg/25 mg 300 mg/12.5 mg 300 mg/25 mg	022107	1	2014-03-07

US Patents and Regulatory Information for aliskiren hemifumarate; hydrochlorothiazide

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	022107-004	Jan 18, 2008		DISCN	Yes	No			Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008		DISCN	Yes	No			Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008		DISCN	Yes	No			Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	Jan 18, 2008		DISCN	Yes	No			Y

Expired US Patents for aliskiren hemifumarate; hydrochlorothiazide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008

International Patents for aliskiren hemifumarate; hydrochlorothiazide

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0713338
Taiwan	200808358
Russian Federation	2491058
European Patent Office	3391878
Morocco	30527
Peru	20080373
Argentina	061565

Supplementary Protection Certificates for aliskiren hemifumarate; hydrochlorothiazide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1915993	132013902215595	Italy		PRODUCT NAME: ALISKIREN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E AMLODIPINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(RASILAMLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/686/001-056, 20110414
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
1915993	2013C/068	Belgium		PRODUCT NAME: COMBINAISON COMPRENANT L'ALISKIREN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET L'AMLOPINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/11/686/001 20110415
1602370	11/2009	Austria		PRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: LI 58935 20081028
2305232	132019000000150	Italy		PRODUCT NAME: ALISKIREN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E IDROCLOROTIAZIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(RASILEZ HCT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/08/491, 20090120
0678503	C00678503/01	Switzerland		PRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007
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

Market Dynamics and Financial Trajectory for ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

Last updated: July 28, 2025

Introduction

Aliskiren Hemifumarate combined with Hydrochlorothiazide (HCTZ) forms a fixed-dose combination (FDC) widely utilized in managing hypertension, particularly resistant cases. This dual therapy offers a synergistic effect, targeting multiple pathways of blood pressure regulation. As the global burden of hypertension escalates, the pharmaceutical landscape surrounding this combination drug is experiencing significant shifts driven by regulatory, clinical, and market factors.

This article explores the current market dynamics and forecasts the financial trajectory for Aliskiren Hemifumarate and Hydrochlorothiazide, considering factors like patent status, commercialization trends, competitive landscape, and evolving healthcare policies.

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Market Overview

Hypertension remains a primary risk factor for cardiovascular disease globally, with an estimated 1.28 billion affected individuals worldwide as of 2021 [1]. The pharmacological management landscape includes ACE inhibitors, angiotensin receptor blockers (ARBs), diuretics, and direct renin inhibitors like Aliskiren.

Aliskiren, a direct renin inhibitor approved by the FDA in 2007, offers an alternative to ACE inhibitors and ARBs, with the benefit of reducing the activation of the renin-angiotensin-aldosterone system (RAAS). When combined with Hydrochlorothiazide, a well-established diuretic, it enhances antihypertensive efficacy, especially in patients requiring multidrug therapy.

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Market Dynamics

1. Competitive Landscape

The antibiotics and antihypertensives markets are intensely competitive, dominated by generic formulations and a handful of branded drugs. Although Aliskiren is less dominant compared to ACE inhibitors and ARBs, the combination formulations have carved a niche owing to elevated compliance from fixed dosing.

Generic Entry and Price Competition:
Since patent expiration in many regions, generic manufacturers have introduced cost-effective versions of Aliskiren-HCTZ, exerting downward pressure on prices. Lower entry barriers accelerate volume sales but erode margins for branded products.

Pipeline and Innovator Activity:
Pharmaceutical companies have limited ongoing pipeline development for this specific combination, partly due to patent expiries. However, some firms are investigating novel formulations with improved bioavailability or reduced side effects, potentially revitalizing market interest.

2. Regulatory Trends

Regulatory agencies increasingly favor data supporting fixed-dose combinations’ efficacy and safety. The US FDA’s guidance on generic fixed-dose combinations simplifies approval pathways, encouraging more entrants into this segment. Conversely, any new combination or formulation requires substantial clinical validation, impacting time-to-market.

3. Clinical Adoption and Prescribing Trends

Physicians favor FDCs like Aliskiren-HCTZ for patient adherence, especially in resistant hypertension. Post-trial data have shown improved compliance rates, fostering sustained demand. However, safety concerns, notably hyperkalemia and renal impairment, necessitate careful patient selection, which can influence prescribing patterns.

4. Distribution and Market Penetration

Emerging markets such as Asia-Pacific, Latin America, and Africa exhibit growing hypertensive populations with limited healthcare access, thus representing high-volume opportunities for low-cost generics. Wide-scale adoption in these regions can significantly influence global sales, despite comparatively low margins.

5. Patent Landscape and Intellectual Property

While Aliskiren’s patent life has largely expired in key jurisdictions, combination patents, if existing, can extend exclusivity periods. The expiration of patents typically triggers increased generic competition but also short-term revenue declines.

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Financial Trajectory Analysis

Current Revenue Estimates

Due to limited proprietary data, estimations rely on market reports and licensing disclosures. The global antihypertensive drugs market was valued at approximately USD 16 billion in 2021, with combination therapies accounting for about 30% [2].

Aliskiren-HCTZ formulations currently contribute a modest segment, estimated at USD 300–500 million annually, primarily driven by developed markets and emerging economies.

Forecasting Growth Trends

The Compound Annual Growth Rate (CAGR) for the hypertension medications segment is projected at approximately 4-6% through 2030 [3]. Fixed-dose combinations are expected to outperform monotherapies, driven by adherence benefits.

Specific to Aliskiren-HCTZ:

• Short-term (1-3 years): Market growth may be limited due to patent expiration, increased generic competition, and saturation in mature markets.

• Medium to Long-term (4-10 years): The expansion into emerging markets, coupled with the introduction of cost-effective generics, may accelerate sales growth, with potential CAGR reaching 7-10%, contingent on regulatory approvals and healthcare infrastructure enhancements.

Factors Impacting Revenue

• Pricing Dynamics: Price erosion from generics can reduce per-unit revenue but may be offset by higher volume sales.

• Market Penetration: Expansion into developing regions and institutional procurement can significantly influence financial performance.

• Regulatory and Safety Considerations: Any adverse events or safety concerns can lead to market withdrawals or usage restrictions, impacting revenue.

• Innovative Formulations: Introduction of once-daily, combination products with improved tolerability can command premium pricing and bolster revenues.

Potential Market Risks

• Generic Competition: The entrance of multiple generic manufacturers can dilute market share.

• Pricing Pressures: Price cuts mandated by healthcare policies or tendering processes can erode profit margins.

• Shifts in Treatment Guidelines: Adoption of newer antihypertensive agents or combination therapies may reduce validity or preference for Aliskiren-HCTZ.

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Strategic Outlook and Recommendations

Pharmaceutical companies should focus on:

• Enhancing the value proposition via improved formulations with better safety profiles.
• Expanding access in emerging markets, leveraging local manufacturing and distribution.
• Investing in post-marketing surveillance to reinforce safety and efficacy, supporting market competitiveness.
• Collaborating with healthcare providers and payers to secure formulary inclusion and favorable reimbursement policies.

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Key Takeaways

• The global market for Aliskiren Hemifumarate with Hydrochlorothiazide is evolving amid patent expiries and increasing generic penetration.
• Growth is primarily driven by demand in emerging markets and the attractiveness of fixed-dose combinations for improving patient compliance.
• Revenue projections indicate moderate growth in mature markets but significant upside in developing regions.
• Price competition and regulatory hurdles pose ongoing risks, necessitating innovation and strategic positioning.
• The future financial trajectory hinges on successful market expansion, regulatory acceptance, and optimized formulations.

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FAQs

1. What factors influence the adoption of Aliskiren-HCTZ globally?
Adoption depends on clinical efficacy, safety profiles, regulatory approvals, pricing, healthcare infrastructure, and physician prescribing habits. Patient adherence benefits and cost considerations are pivotal, especially in emerging markets.

2. How does patent expiration impact the market for Aliskiren-HCTZ?
Patent expiration typically leads to increased generic entry, reducing prices and profit margins but expanding access and volume sales.

3. Are there any ongoing developments to improve the existing Aliskiren-HCTZ formulations?
Researchers are exploring formulations with better bioavailability, reduced side effects, and once-daily dosing to enhance compliance and safety.

4. What are the main competitive threats facing Aliskiren-HCTZ?
Competition from other antihypertensive fixed-dose combinations, newer drug classes, and regulatory hurdles can threaten market share.

5. Which regions offer the greatest growth potential for Aliskiren-HCTZ?
Emerging markets in Asia, Africa, and Latin America present substantial growth opportunities due to rising hypertension prevalence and demand for affordable therapies.

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References

[1] World Health Organization. (2021). Hypertension Fact Sheet.

[2] MarketWatch. (2022). Global Antihypertensive Drugs Market Size and Forecast.

[3] Grand View Research. (2022). Hypertension Drugs Market Size, Share & Trends Analysis.