Aliskiren hemifumarate; valsartan - Generic Drug Details

What are the generic drug sources for aliskiren hemifumarate; valsartan and what is the scope of patent protection?

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

International Patents for aliskiren hemifumarate; valsartan

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2006132668
Hong Kong	1059212
Japan	2013213061	SYNERGISTIC COMBINATION COMPRISING RENIN INHIBITOR FOR CARDIOVASCULAR DISEASES
Poland	400914
New Zealand	568764	Synergistic combinations comprising a renin inhibitor and an aldosterone synthase inhibitor
South Korea	20100114904

Supplementary Protection Certificates for aliskiren hemifumarate; valsartan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1915993	92315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
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
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
1507558	132012902049405	Italy		PRODUCT NAME: ALISKIREN, AMLODIPINA, IDROCLOROTIAZIDE(RASITRIO); AUTHORISATION NUMBER(S) AND DATE(S): 61678/01/02/03/04/05, 20110705;EU/1/11/730/001-060, 20111122
0678503	C00678503/04	Switzerland		PRODUCT NAME: ALISKIREN + AMLODIPIN; REGISTRATION NO/DATE: SWISSMEDIC 61454 05.07.2011

Market Overview and Financial Trajectory for Aliskiren Hemifumarate and Valsartan

Last updated: February 12, 2026

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What are the current market positions of aliskiren hemifumarate and valsartan?

Aliskiren hemifumarate and valsartan are prescribed for hypertension and cardiovascular disorders. Valsartan, an angiotensin II receptor blocker (ARB), has a globally established presence. Aliskiren, a direct renin inhibitor, is less prevalent due to limited adoption and patent exclusivity issues.

Distribution and Adoption:

• Valsartan: Dominanto in ARB class, with a global market share exceeding 25% within antihypertensive drugs.
• Aliskiren: Holds a small market segment, approximately 2-3%, primarily in combination therapies or specific cases.

Patent and Patent Expiry:

• Valsartan: Patent expired in most regions (e.g., in the US in 2019), leading to generic entry.
• Aliskiren: Patent protections extended through at least 2024, limiting generic competition.

How have recent patent expirations affected market share and pricing?

Patent cliffs have resulted in significant price erosion and market share shifts:

Drug	Patent Expiry	Post-Patent Market Impact	Price Reduction	Generic Entry
Valsartan	2019 (US)	Rapid generic entry, price drops of 80%+ in some markets	80-90%	Yes
Aliskiren	2024 projected	Market remains limited; limited generic competition expected	N/A (awaits patent expiry)	Not yet, as of late 2022

Implication:
The availability of generics for valsartan has depressed revenue potential for brand manufacturers. For aliskiren, patent exclusivity sustains higher margins temporarily, but prospects diminish as expiry nears.

What are the revenue projections and growth drivers?

Current Revenue Estimates (2022):

• Valsartan: Estimated global sales of approximately $4 billion (IQVIA data).
• Aliskiren: Estimated at around $200 million worldwide.

Forecasts (2023-2030):

• Valsartan: Revenue expected to decline by 30% over next five years, driven by generic competition.
• Aliskiren: Potential growth driven by combination therapies and clinical interest, but constrained by competition from other antihypertensives and adverse safety profiles.

Key growth drivers:

• Generic availability: Increases volume but depresses prices.
• New formulations: Fixed-dose combinations (e.g., valsartan/hydrochlorothiazide) expand market share.
• Cardiovascular disease prevalence: Rising global rates of hypertension and related conditions drive demand.

What are regulatory and market access considerations?

• Regulatory approvals: Several markets favor generics due to cost savings, accelerating off-patent product uptake.
• Pricing policies: Governments and payers enforce price caps affecting revenue margins.
• Labeling and safety concerns: Reports linking valsartan to contamination issues (e.g., nitrosamines) prompted recalls, impacting sales temporarily.

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How will competitive and scientific developments influence the market?

Emerging therapies:

• New classes of antihypertensive drugs (e.g., neprilysin inhibitors) threaten to displace existing ARBs and renin inhibitors.
• The combination of pharmacological agents and personalized medicine approaches expands treatment options.

Research and clinical data:

• Ongoing trials assess the safety and efficacy of aliskiren in new indications, such as heart failure, but results remain mixed.
• Valsartan’s safety profile, especially concerning adverse effects and recalls, impacts market confidence.

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What is the financial outlook for stakeholders?

Stakeholder	Impacted Areas	Outlook
Pharmaceutical manufacturers	Revenue erosion from generics; potential patents filings for new formulations	Downward trend for valsartan; uncertain for aliskiren pre-2024
Investors	Declining sales post-patent expiry; need for diversification	Increased risk; focus on pipeline or new drugs
Healthcare payers	Cost savings from generics; pressure to limit high-cost branded drugs	Favor generic prescribing; price negotiations intensify

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Key Takeaways

• Valsartan is transitioning from a branded to a generic-dominated market, with sales declining sharply since patent expiry.
• Aliskiren benefits from patent protection but faces long-term profitability pressures as expiry approaches.
• Market dynamics are shaped by patent status, generics, regulatory environment, and emerging therapies.
• Revenue growth prospects are limited; significant decline expected for valsartan, while aliskiren's trajectory depends on clinical outcomes and patent timelines.
• Stakeholders must navigate pricing pressures, safety concerns, and evolving treatment paradigms to sustain profitability.

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FAQs

1. How will patent expiries impact the future sales of valsartan?
Patent expiries led to broad generic entry, drastically reducing sales revenue. Future sales will rely on market share retained by brand manufacturers through patent extensions or niche indications.

2. Can aliskiren regain market share beyond its patent period?
Unlikely. The drug faces competition from more established antihypertensive classes and uncertain clinical benefits. Post-patent, its market share is expected to decline unless new indications emerge.

3. What regulatory factors could affect these drugs' market prospects?
Regulatory actions related to safety recalls or new approval guidelines can limit sales or facilitate generic entry, respectively.

4. What are the prospects for combination formulations involving valsartan or aliskiren?
Fixed-dose combinations (e.g., valsartan/amlodipine) have sustained market relevance, often commanding higher prices and improved adherence, which partially offsets sales decline.

5. How are emerging therapies influencing the hypertension drug market?
New drug classes and personalized treatment regimens are reducing reliance on traditional ARBs and renin inhibitors, intensifying competition and limiting revenue growth for existing drugs.

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Sources

1. IQVIA. Global Oncology Trends. 2022.
2. FDA. Valsartan Recall and Safety Notices. 2019.
3. Statista. Hypertension Drug Market Revenue Forecast. 2022.
4. MarketWatch. Aliskiren Hemifumarate Patent Status. 2022.
5. EvaluatePharma. Pharmaceutical Revenue Projections. 2022.

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