ALISKIREN HEMIFUMARATE; VALSARTAN - Generic Drug Details

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

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

Aliskiren hemifumarate; valsartan has ninety-three patent family members in thirty-one countries.

Summary for ALISKIREN HEMIFUMARATE; VALSARTAN

International Patents:	93
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
DailyMed Link:	ALISKIREN HEMIFUMARATE; VALSARTAN at DailyMed

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

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; VALSARTAN

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
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; VALSARTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-001	Sep 16, 2009		DISCN	No	No			Y
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-002	Sep 16, 2009		DISCN	No	No			Y

Expired US Patents for ALISKIREN HEMIFUMARATE; VALSARTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-001	Sep 16, 2009
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-002	Sep 16, 2009
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-002	Sep 16, 2009
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-001	Sep 16, 2009

International Patents for ALISKIREN HEMIFUMARATE; VALSARTAN

Country	Patent Number	Title	Estimated Expiration
Poland	400914
European Patent Office	2305233
New Zealand	568764	Synergistic combinations comprising a renin inhibitor and an aldosterone synthase inhibitor
Australia	2368002
European Patent Office	1930000

Supplementary Protection Certificates for ALISKIREN HEMIFUMARATE; VALSARTAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2305232	301005	Netherlands		PRODUCT NAME: ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/08/491 20090120
1602370	09C0020	France		PRODUCT NAME: COMBINAISON COMRENANT L’ALISKIREN SOUS FORME DE BAE LIBRE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, ET L’HYDROCHLOROTHIAZIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/08/491/001 DU 20090116; REGISTRATION NO/DATE AT EEC: 58935 01-04 DU 20081028
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
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
2305232	122019000098	Germany		PRODUCT NAME: ALISKIREN HEMIFUMARAT UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116

Market Dynamics and Financial Trajectory for Aliskiren Hemifumarate and Valsartan

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape for antihypertensive medications is characterized by rapid innovation, evolving regulatory environments, and shifting market demands. Among the key players are aliskiren hemifumarate and valsartan, both pivotal in addressing hypertension and cardiovascular risk. This report analyzes the current market dynamics, regulatory influences, competitive landscape, and financial projections for these drugs, providing insights for stakeholders across the pharmaceutical value chain.

Market Overview and Demand Drivers

Aliskiren hemifumarate and valsartan serve as critical components in hypertension management, contributing to a globally sizable and resilient market estimated to surpass USD 20 billion annually. The global hypertension treatment market is projected to grow at a compound annual growth rate (CAGR) of approximately 3-4% over the next five years (2023–2028)[1].

Aliskiren Hemifumarate

Since its FDA approval in 2007, aliskiren has positioned itself as the first direct renin inhibitor on the market, targeting patients inadequately controlled by other antihypertensives. While its market share has been modest relative to ACE inhibitors and ARBs, its unique mechanism attracts a niche segment, especially among patients with specific contraindications.

Valsartan

Valsartan, an angiotensin II receptor blocker (ARB), gained prominence following its approval in 1995 and consolidated market presence over decades. Despite value-driven competitors, valsartan remains a preferred choice owing to its proven efficacy, favorable safety profile, and extensive generic availability. Its longstanding market penetration ensures continued appetite among clinicians and health systems.

Regulatory and Patent Landscape

Aliskiren

The patent life of aliskiren was granted in the late 1990s, with exclusivity expiring in the mid-2020s in several jurisdictions[2]. The expiration invites competition from generic manufacturers, impacting pricing and market share dynamics.

Valsartan

The patent for valsartan expired in various regions around 2012–2013, giving rise to a robust generic market. Regulatory challenges emerged after the 2018 recall due to N-nitrosodimethylamine (NDMA) impurities, causing temporary disruptions but subsequently restoring market stability[3]. The removal of patent barriers expands access but also heightens price competition.

Market Challenges and Opportunities

Challenges:

• Generic Competition: The expiration of patents substantially compresss margins, compelling brand-name manufacturers to innovate or differentiate.

• Regulatory Scrutiny: The NDMA impurity issue for valsartan highlighted the importance of manufacturing quality controls, impacting trust and regulatory clarity.

• Market Saturation: Established drugs like valsartan face saturation; growth hinges on population aging and treatment expansion.

Opportunities:

• Line Extensions and Fixed-Dose Combinations (FDCs): Development of combined formulations enhances adherence, capturing incremental market segments.

• Specialty Indications: Emerging evidence supports expanding indications to heart failure or diabetic nephropathy, broadening revenue streams.

• Emerging Markets: Rapid urbanization and increasing hypertension prevalence in Asia, Africa, and Latin America present significant growth prospects.

Financial Trajectory and Revenue Forecasts

Aliskiren Hemifumarate

Projected revenue for aliskiren is expected to decline entering the late 2020s, reflecting patent expiry and generic entry. However, niche adoption in combination therapies—such as aliskiren-based FDCs—may provide offsets, especially in markets prioritizing improved medication adherence.

• Forecast: Analysts predict a CAGR of approximately 1-2% over the next five years for aliskiren, driven mainly by formulary approvals and regional expansions in Asia-Pacific markets[4].

Valsartan

Post-2018 recall impacts have phased out; however, the drug remains a strong revenue generator in its generics form. The transition toward biosimilars and alternative ARBs potentially diminishes its market dominance but supports continued revenues through innovation and quality improvements.

• Forecast: Revenues are projected to stabilize in the USD 1.5–2 billion range annually, with minimal growth expected unless driven by new formulations or indications[5].

Impact of Regulatory Changes and Patent Expirations

Patent expirations for both drugs catalyzed price competition, decreasing per-unit revenue. Future projections suggest that generic penetration will continue to erode the market share of branded versions, especially in mature markets.

Competitive Landscape

The proliferation of generics constrains margins, with key players including Novartis, Teva, and Mylan primarily dominating the affordable ARB segment. Innovative entrants focusing on combination therapies and targeted indications vie for market share, escalating competition.

Pharmaceutical companies are increasingly investing in digital health solutions and personalized medicine approaches, promising new revenue streams and differentiation.

Innovation and Pipeline Opportunities

While both drugs face commoditization pressures, developments in fixed-dose combinations (e.g., valsartan with hydrochlorothiazide oramlodipine) offer growth avenues by simplifying regimens and improving patient adherence.

Advances in pharmacogenomics may enable tailored therapy selection, expanding market reach.

Conclusion

The landscape for aliskiren hemifumarate and valsartan is evolving under patent expirations, regulatory pressures, and market saturation. While immediate revenues face compression, strategic investments in combination therapies, emerging markets, and pipeline innovation will be vital for sustaining long-term growth.

Key Takeaways

• Patents for aliskiren are nearing expiration, with generic competition expected to reduce market revenues significantly.

• Valsartan maintains substantial sales margins through generic availability, but revenue growth prospects are limited without formulation innovations.

• Market expansion in emerging regions and development of fixed-dose combinations present significant growth opportunities.

• Regulatory challenges, such as recalls and impurity issues, underscore the need for robust quality assurance protocols.

• Stakeholders should prioritize pipeline diversification, digital integration, and targeted indications to remain competitive.

FAQs

1. How will patent expirations affect the revenues of aliskiren and valsartan?
Patent expirations have led to a surge in generic availability, significantly reducing brand-name drug prices and margins. While volumes may remain stable or increase, overall revenues for branded versions are expected to decline unless offset by new formulations or indications.

2. Are there any recent innovations or formulations under development for these drugs?
Yes; the industry is focusing on fixed-dose combinations, such as valsartan with amlodipine or hydrochlorothiazide, which improve adherence and expand indications. Research into novel delivery systems and pharmacogenomic-based therapy is ongoing.

3. What regional markets offer the most growth potential for these drugs?
Emerging markets, especially in Asia, Africa, and Latin America, due to increasing hypertension prevalence and expanding healthcare infrastructure, provide the most significant growth opportunities.

4. How did regulatory issues impact valsartan's market?
The 2018 NDMA impurity recall temporarily reduced market confidence and sales. Post-regulation adjustments and improved manufacturing quality have stabilized the market.

5. What strategic moves should pharmaceutical companies consider to sustain growth?
Investing in pipeline diversification, formulating combination therapies, expanding into emerging markets, leveraging digital health, and focusing on personalized medicine offer pathways to sustain and enhance long-term revenue.

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References

[1] Global Data, "Hypertension Market Analysis," 2022
[2] U.S. FDA, "Aliskiren Hemifumarate: Approvals and Patent Data," 2007
[3] EMA, "Valsartan and NDMA Recall Decisions," 2018
[4] MarketWatch, "Aliskiren Market Forecast," 2022
[5] IQVIA, "Global ARB Market Trends," 2022