Aliskiren hemifumarate; amlodipine besylate - Generic Drug Details

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

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

Aliskiren hemifumarate; amlodipine besylate has twenty-three patent family members in twenty-one countries.

Summary for aliskiren hemifumarate; amlodipine besylate

International Patents:	23
US Patents:	1
Tradenames:	2
Applicants:	1
NDAs:	2
DailyMed Link:	aliskiren hemifumarate; amlodipine besylate at DailyMed

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

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; amlodipine besylate

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
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; amlodipine besylate

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	200045-003	Dec 21, 2010		DISCN	No	No
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-004	Aug 26, 2010		DISCN	No	No			Y
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-003	Aug 26, 2010		DISCN	No	No			Y
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-001	Dec 21, 2010		DISCN	No	No
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-002	Aug 26, 2010		DISCN	No	No			Y

Expired US Patents for aliskiren hemifumarate; amlodipine besylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-004	Aug 26, 2010
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-001	Aug 26, 2010
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-003	Aug 26, 2010
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-002	Aug 26, 2010

International Patents for aliskiren hemifumarate; amlodipine besylate

Country	Patent Number	Title	Estimated Expiration
Argentina	073384
Australia	2009292908
Brazil	PI0919350	combinação de dose fixa oral farmacêutica na forma de uma comprimido monocamada, bem como seu uso e seu método de preparação
Canada	2736257	FORMULATIONS GALENIQUES DE COMPOSES ORGANIQUES (GALENICAL FORMULATIONS OF ORGANIC COMPOUNDS)
Chile	2011000594	Combinacion farmaceutica que comprende: a) 10-45% de alisquireno, b) 0,5-5% de amlodipina, c) 2-15% de un desintegrante, d) 1-60% de un diluyente, e) 0,1-20% de un aglutinante, f) 0,1-5% de un lubricante, g) 0,05-5% de un derrapante y h) opcionalmente un relleno; metodo de preparacion; uso para tratar hipertension.

Supplementary Protection Certificates for aliskiren hemifumarate; amlodipine besylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1915993	CA 2013 00062	Denmark		PRODUCT NAME: KOMBINATION OMFATTENDE ALISKIREN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HEMIFUMARAT, OG AMLODIPIN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BENSYLAT; REG. NO/DATE: EU/1/11/686/001/056 20110418
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
1915993	300625	Netherlands		PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
0678503	C300296	Netherlands		PRODUCT NAME: ALISKIREN OF EEN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
0678503	C300499	Netherlands		PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114

Last updated: February 15, 2026

What is the current market landscape for aliskiren hemifumarate and amlodipine besylate?

Aliskiren hemifumarate and amlodipine besylate are antihypertensive agents prescribed for high blood pressure management. The combined market for these drugs is driven by rising hypertension prevalence globally, aging populations, and ongoing generic penetration. While amlodipine is a top-selling calcium channel blocker, aliskiren, a direct renin inhibitor, has a smaller footprint due to limited adoption and safety concerns.

How does the market size compare between the two drugs?

Parameter	Amlodipine besylate	Aliskiren hemifumarate
Global Market (2022)	Estimated at $8.2 billion[1]	Approximately $750 million[2]
Market Growth Rate (CAGR 2022-2028)	4.5%	3.2%
Major Regions	North America, Europe, Asia-Pacific	North America, Europe, Asia-Pacific
Key Factors	High generic availability, broad adoption	Limited by safety concerns, competition

Amlodipine's dominance stems from its established efficacy and low-cost generics. Aliskiren's smaller market share results from safety issues and patent expirations not significantly expanding its scope.

What are the drivers affecting future market growth?

Increasing Hypertension Prevalence

Hypertension affects over 1.3 billion worldwide[3], with projections indicating continuous growth. Asia-Pacific exhibits the highest incremental increases, driven by urbanization and aging populations.

Patent Expirations and Generic Competition

Major patents for amlodipine expired in the past decade, leading to price reductions and wider accessibility. Aliskiren patents also expired in selected markets, but market penetration remains limited due to safety profiles.

Combination Therapies

Surging adoption of fixed-dose combinations (FDCs) enhances patient compliance. Many formulations combine amlodipine with other agents like benazepril or valsartan, augmenting market penetration.

Regulatory and Safety Considerations

Aliskiren faced safety warnings from FDA in 2012 about increased risks of adverse events when used with ACE inhibitors or ARBs in diabetic patients[4]. This impacted physicians' prescribing habits and constrained market expansion.

Emerging Markets

Growth in emerging economies accelerates antihypertensive drug sales, especially where healthcare infrastructure improves. These markets favor low-cost generics, aiding amlodipine's distribution.

How does financial performance forecast over the next five years?

Revenue Trajectory

• Amlodipine: Expected CAGR of approximately 4.5%; revenues could reach around $10.4 billion by 2028[1].
• Aliskiren: Projected CAGR of around 3.2%; revenues may increase to approximately $950 million[2].

Investment Trends

Pharmaceutical companies prioritize extending the lifecycle of existing molecules through new formulations. For aliskiren, this means developing combination products or re-evaluating safety profiles to regain market share.

R&D Focus

Investments target enhancing previous safety concerns and exploring novel delivery systems. There is limited R&D focus on aliskiren as a standalone molecule due to its constrained growth potential.

Pricing Dynamics

Pricing pressures persist for generics, especially in high-volume regions. Amlodipine prices are expected to continue declining, whereas aliskiren's price stability depends on patent litigation and regulatory decisions.

What are the key risks impacting market and financial prospects?

• Regulatory Risks: Safety warnings can restrict or withdraw approval.
• Market Competition: Numerous alternatives, including ARBs and diuretics, compete with both drugs.
• Patent Litigation: Ongoing legal disputes may impact exclusivity and pricing.
• Generic Adoption: Rapid generic entry dampens revenue growth.

Summary of the financial trajectory

Year	Amlodipine Revenue	Aliskiren Revenue
2022	$8.2 billion	$750 million
2025	~$9.2 billion	~$850 million
2028	~$10.4 billion	~$950 million

Key Takeaways

• Amlodipine dominates the antihypertensive segment with steady, modest growth.
• Aliskiren's market remains limited; growth depends on safety profile improvements and formulation innovations.
• Rising hypertension prevalence supports overall demand, but price competition and patent litigations are significant factors.
• Emerging markets contribute substantially to future growth, driven by affordability and expanding healthcare infrastructure.
• R&D initiatives focus more on combination formulations than new molecules for these existing drugs.

Frequently Asked Questions

1. Is aliskiren still relevant given safety warnings?

Yes. While safety concerns impacted its use after 2012, ongoing research and potential reformulations could restore its role. Currently, it is prescribed selectively.

2. How does patent expiry influence the market?

Patent expiries lead to increased generic competition, lowering prices and increasing access but reducing revenue for originators.

3. Will combination therapies affect market share?

Yes. Fixed-dose combinations improve adherence, and formulations with amlodipine remain dominant due to proven efficacy and low cost.

4. How significant is the emerging market growth?

Significantly. Asia-Pacific and Latin America account for the majority of growth driven by urbanization and increased health expenditure.

5. Are there promising pipeline developments?

Limited. Most innovation focuses on reformulation, delivery systems, or combination formulations rather than new chemical entities.

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References

[1] MarketWatch. "Amlodipine Market Size, Share & Trends." 2022. [2] GlobalData. "Aliskiren Market Overview." 2022. [3] World Health Organization. "Hypertension Fact Sheet." 2022. [4] FDA. "Safety Warning on Aliskiren." 2012.