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

Constraining patent/regulatory exclusivity:

8,168,616

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	8,168,616		Y
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-002	Sep 16, 2009		DISCN	No	No	8,168,616		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	022217-002	Sep 16, 2009	5,399,578
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-001	Sep 16, 2009	5,399,578
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-002	Sep 16, 2009	5,559,111
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-001	Sep 16, 2009	5,559,111

International Patents for ALISKIREN HEMIFUMARATE; VALSARTAN

Country	Patent Number	Title	Estimated Expiration
Hungary	0301841
South Korea	20030051753
China	1474690
Slovenia	1915993
Denmark	1915993
Ecuador	SP034603	COMBINACIONES SINERGICAS QUE COMPRENDEN UN INHIBIDOR DE RENINA PARA ENFERMEDADES CARDIOVASCULARES
South Korea	20080011355

Supplementary Protection Certificates for ALISKIREN HEMIFUMARATE; VALSARTAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1915993	1390055-0	Sweden		PRODUCT NAME: KOMBINATION INNEFATTANDE ALISKIREN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH AMLODIPIN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/11/686/001 20110414
1507558	C300528	Netherlands		PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
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
2305232	C201930070	Spain		PRODUCT NAME: ALISKIREN HEMIFUMARATO + HIDROCLOROTIAZIDA; NATIONAL AUTHORISATION NUMBER: EU/1/08/491/001-080; DATE OF AUTHORISATION: 20090116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/08/491/001-080; DATE OF FIRST AUTHORISATION IN EEA: 20090116
1507558	113 5008-2012	Slovakia		PRODUCT NAME: ALISKIREN / AMLODIPIN / HYDROCHLORTIAZID; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - EU/1/11/730/060 20111122; FIRST REGISTRATION: CH 61678 01 - 61678 05 20110705
1507558	12C0033	France		PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705
0678503	C00678503/04	Switzerland		PRODUCT NAME: ALISKIREN + AMLODIPIN; REGISTRATION NO/DATE: SWISSMEDIC 61454 05.07.2011

Aliskiren Hemifumarate / Valsartan (Combination) — Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

What does the product landscape look like for aliskiren hemifumarate + valsartan?

The fixed-dose combination of aliskiren hemifumarate and valsartan targets hypertension. The commercial landscape is shaped by three forces: (1) regulatory status changes driven by safety outcomes, (2) shift in payer and prescriber behavior toward RAAS competitors with more favorable risk-benefit profiles, and (3) erosion of addressable volume from loss of clinical positioning and line-of-therapy placement.

Regulatory and clinical positioning tailwinds that reversed

The combination’s core mechanism is dual RAAS blockade (aliskiren inhibits renin; valsartan blocks the AT1 receptor). That pharmacology translated into early sales momentum but later faced hard headwinds when safety signals emerged in large outcomes trials that involved renin inhibitor strategy and dual RAAS approaches. This drove global label restrictions/withdrawals for aliskiren-containing regimens in key patient populations.

• In type 2 diabetes with renal impairment, aliskiren-based therapy faced strong label restrictions due to safety findings.
  Source: EMA summary of aliskiren restrictions (EU label context). [1]
• In the broader cardiorenal outcomes context of aliskiren-based therapy, the ALTITUDE program informed regulators and prescribers that risk outweighed benefit for many RAAS combination use cases.
  Source: Clinical trial outcome reporting and regulator-facing evidence base. [2]

Net effect on the market: reduced eligible populations, constrained switching and continuation behavior, and diminished enthusiasm for RAAS dual blockade.

How do regulatory constraints shape market demand?

Regulatory posture directly reduces sales-addressable demand by:

• Narrowing populations where dual RAAS is permitted.
• Lowering prescriber confidence in escalation beyond monotherapy or standard RAAS agents.
• Increasing payer friction for coverage of fixed-dose dual RAAS products where alternatives exist.

Label-adjacent demand compression

The highest-risk use case for aliskiren inclusion (notably diabetes with renal impairment) became restricted across major jurisdictions, pushing clinicians toward:

• ACE inhibitor + ARB combinations (where still permitted by label and guideline nuance) or
• Single-agent RAAS strategies combined with non-RAAS agents (calcium channel blockers, thiazide-like diuretics).

That behavior depresses both initiation and long-term adherence for aliskiren hemifumarate + valsartan fixed-dose combinations.

Primary source anchor: EMA labeling restrictions framework for aliskiren-containing products. [1]
Mechanism-of-evidence anchor: ALTITUDE safety-driven conclusions that underpinned subsequent restriction decisions. [2]

What is the competitive structure and how does it affect pricing power?

In hypertension combination therapy, the competitive set is dense: ARBs, ACE inhibitors, and fixed-dose combinations with thiazide(-like) diuretics and calcium channel blockers. Fixed-dose ARB combos generally retain strong demand because they combine efficacy with manageable risk.

Dual RAAS adds cost and clinical complexity without durable outcomes justification in most patient segments after the safety evidence. That changes pricing power and formulary outcomes:

• Payers prefer clinically mainstream fixed-dose regimens (ARB + diuretic or ARB + CCB).
• Clinicians favor combinations aligned with guideline-first patterns and fewer safety constraints.

Result: aliskiren hemifumarate + valsartan faces structurally weaker pricing leverage versus broad ARB combination competitors.

How has the market volume trajectory likely evolved post-safety evidence?

Post-safety evidence, the market typically experiences: 1) Early peak then plateau as initial adopters transition off restricted populations. 2) Formulary tightening that limits new prescriber uptake. 3) Reduced persistence as patients switch to alternative fixed-dose regimens or monotherapy-plus-add-on strategies.

Even where the product remains authorized, the demand curve flattens because the combination loses the “must-use” logic that would otherwise support sustained expansion.

This demand trajectory is consistent with the regulatory restrictions based on aliskiren risk-benefit in key groups. [1][2]

What is the likely financial trajectory for the combination?

A stable or declining revenue trajectory is the base case for RAAS dual blockade fixed-dose combinations once regulators restrict use cases and guidelines narrow clinical priority. The financial trajectory follows typical playbook outcomes:

• Revenue declines driven by lower addressable patient populations and conversion rates.
• Net sales compression from formulary displacement by better-accepted ARB combinations.
• Profitability pressure from reduced scale and greater discounting to maintain share.

The combination’s financial trajectory also depends on patent clock and regulatory exclusivity across key markets; however, no market-wide revenue figures are provided in the available sources used here. What can be stated from the evidence record is that safety-driven restrictions constrain the long-run growth vector and reduce premium justification.

Evidence anchors: safety outcomes and the resulting regulatory posture. [1][2]

---

What does the evidence base say about the outcome risk that drove the pivot?

ALTITUDE and safety signals underpinning restrictions

The ALTITUDE trial investigated aliskiren in high-risk type 2 diabetes populations and informed regulators that serious adverse events and lack of benefit outweighed expected outcomes. This translated into later label restrictions affecting eligibility for aliskiren-containing regimens. [2]

EMA framework for restricted use

The EMA documentation ties aliskiren restrictions to safety outcomes in specific patient subgroups and dual RAAS contexts, reflecting reduced permissible use after evidence accumulation. [1]

---

How do these dynamics translate into investor or R&D implications?

For pipeline strategy and commercialization planning, the combination’s market dynamics suggest:

• Limited upside from broad hypertension expansion, because risk-benefit perception and regulatory constraints dampen physician adoption.
• High substitution risk as prescribers can achieve similar BP targets with safer, mainstream combinations.
• Lower likelihood of payer support strength versus ARB-based non-renin-inhibitor combinations.

The commercial reality is shaped less by pharmacologic plausibility and more by safety evidence, eligibility rules, and formulary behavior.

---

Market snapshot: demand drivers vs constraints (transactional view)

Factor	Direction for aliskiren hemifumarate + valsartan	Market impact mechanism
Dual RAAS efficacy rationale	Negative long-run	Safety override reduces eligible use and guideline placement
Safety evidence (high-risk populations)	Negative	Restricts populations and discourages switching to fixed-dose dual RAAS
Regulatory posture	Negative	Label constraints reduce initiation and persistence
Competitive set (ARB combos with diuretics/CCBs)	Negative	Payers and clinicians default to better-accepted fixed-dose options
Price/payer leverage	Negative	Displacement pressure forces discounting and limits premium pricing

Primary evidence for risk and restriction drivers: EMA aliskiren restrictions and ALTITUDE conclusions. [1][2]

---

What should be expected for the forward financial trajectory?

Given the safety-driven regulatory retrenchment and substitution dynamics in hypertension fixed-dose combinations, the combination’s forward financial trajectory is best characterized as:

• Flat-to-declining in net revenue as penetration saturates and patients shift to alternative regimens.
• Share volatility driven by formulary changes and therapeutic substitution rather than brand expansion.
• Decreased marketing ROI because the addressable segment is constrained.

The combination’s mechanism remains pharmacologically valid for BP lowering, but the market treats safety-restricted RAAS dual blockade as a niche use with weaker durable demand.

Evidence anchors: regulatory restrictions and ALTITUDE safety outcomes. [1][2]

---

Key Takeaways

• Regulatory restrictions are the primary demand driver: aliskiren-containing regimens face label limitations in key populations tied to safety outcomes. [1]
• ALTITUDE safety outcomes reshaped clinical and payer behavior, reducing long-run growth potential for aliskiren dual RAAS fixed-dose products. [2]
• Competitive substitution is structurally unfavorable versus mainstream ARB fixed-dose combinations (ARB + diuretic or ARB + CCB) with broader eligibility and fewer safety barriers.
• The combination’s financial trajectory is constrained toward flat-to-declining revenue due to restricted eligibility, formulary displacement, and reduced persistence.

---

FAQs

1) Why is aliskiren hemifumarate + valsartan’s market growth weaker than other hypertension fixed-dose combos?

Regulators restricted aliskiren-containing therapy in key high-risk populations based on safety evidence, shrinking the addressable market and lowering prescriber and payer willingness to adopt dual RAAS fixed-dose regimens. [1][2]

2) What evidence most directly drove restriction of aliskiren-containing therapy?

Large outcomes evidence in high-risk type 2 diabetes populations (ALTITUDE) did not support benefit and raised safety concerns, informing downstream restrictions. [2]

3) How do label restrictions change payer behavior?

Restrictions narrow eligible patient populations and increase coverage friction, pushing payers toward broader ARB fixed-dose regimens without renin inhibitor inclusion. [1]

4) Does the BP-lowering mechanism still matter commercially?

Mechanism still supports BP control, but commercial adoption depends on risk-benefit perception and label eligibility. Safety-driven restrictions reduce initiation and persistence, dominating the demand picture. [1][2]

5) What is the most likely long-term product outcome in markets?

A flat-to-declining revenue trajectory is most likely due to constrained use cases, substitution risk, and reduced long-run formulary strength. [1][2]

---

References (APA)

[1] European Medicines Agency. (n.d.). Aliskiren-containing medicines: restrictions and risk information (EMA label-related documentation). European Medicines Agency.
[2] Parving, H.-H., Brenner, B. M., McMurray, J. J. V., et al. (2012). Cardiorenal outcome in high-risk patients with type 2 diabetes treated with aliskiren: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiorenal Endpoints). New England Journal of Medicine.