ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - Generic Drug Details

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

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	022545-001	Aug 26, 2010
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-004	Aug 26, 2010
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-003	Aug 26, 2010

International Patents for ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Country	Patent Number	Title	Estimated Expiration
Japan	2015091830	有機化合物のガレヌス製剤 (GALENICAL FORMULATIONS OF ORGANIC COMPOUNDS)
Morocco	32719	تركيبات خاصة بصناعة الأدوية من مركبات عضوية
Jordan	3239	تركيبات جالينية من مركبات عضوية (Galenical Formulations of Organic Compounds)

Supplementary Protection Certificates for ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0678503	SPC/GB07/060	United Kingdom		PRODUCT NAME: ALISKIREN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/405/001 20070822; UK EU/1/04/405/002 20070822; UK EU/1/04/405/003 20070822; UK EU/1/04/405/004 20070822; UK EU/1/04/405/005 20070822; UK EU/1/04/405/006 20070822; UK EU/1/04/405/007 20070822; UK EU/1/04/405/008 20070822; UK EU/1/04/405/009 20070822; UK EU/1/04/405/010 20070822; UK EU/1/04/405/011 20070822; UK EU/1/04/405/012 20070822; UK EU/1/04/405/013 20070822; UK EU/1/04/405/014 20070822; UK EU/1/04/405/015 20070822; UK EU/1/04/405/016 20070822; UK EU/1/04/405/017 20070822; UK EU/1/04/405/018 20070822; UK EU/1/04/405/019 20070822; UK EU/1/04/405/020 20070822
0678503	C00678503/02	Switzerland		PRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008
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

Market Dynamics and Financial Trajectory for Aliskiren Hemifumarate and Amlodipine Besylate

Last updated: July 30, 2025

---

Introduction

The global cardiovascular pharmacology market continues to evolve, driven by rising hypertension prevalence and the ongoing development of novel therapies. Among key therapeutic agents, aliskiren hemifumarate and amlodipine besylate occupy prominent positions due to their established efficacy in managing hypertension and cardiovascular risk. This analysis explores the market dynamics and financial trajectory of these two drugs, assessing factors influencing their growth, competition, and future prospects.

---

Overview of Aliskiren Hemifumarate and Amlodipine Besylate

Aliskiren hemifumarate is a direct renin inhibitor approved for treating hypertension. It functions by blocking the renin-angiotensin-aldosterone system (RAAS), reducing blood pressure levels. Marketed under the brand Tekturna (or Tekturna HCT in combination formulations), it entered the US market in 2007, with subsequent approvals globally.

Amlodipine besylate, a calcium channel blocker, is among the most prescribed antihypertensive agents, with broad indications for angina and hypertension. Its long half-life and favorable safety profile have solidified its market dominance. Commercialized under brands like Norvasc, it has been a cornerstone of antihypertensive therapy since the 1990s.

---

Market Dynamics

1. Market Size and Growth Drivers

• Rising Hypertension Prevalence: According to the WHO, approximately 1.28 billion adults globally suffer from raised blood pressure, with hypertensive patients projected to reach over 1.5 billion by 2025 [1]. This surge fuels demand for antihypertensive drugs like aliskiren and amlodipine.

• Aging Population: Older adults are disproportionately affected by hypertension, contributing to increased utilization of these medications.

• Lifestyle Factors: Urbanization and sedentary lifestyles propel hypertension incidence, expanding the market.

• Combination Therapies: Growing preference for fixed-dose combinations (FDCs) enhances market growth, especially for drugs like aliskiren, which is increasingly combined with diuretics or other antihypertensives such as amlodipine.

2. Competitive Landscape

• Brand and Generic Competition:

  • Amlodipine besylate benefits from extensive generic manufacturing, making it affordable and widely accessible. Leading pharmaceutical firms like Pfizer and Novartis have generic versions, intensifying price competition.
  • Aliskiren faced a more limited generic landscape initially due to patent protections and clinical safety concerns, but generic forms are now available in some markets post-licensing.

• Efficacy and Safety Concerns:

  • Aliskiren faced scrutiny after studies like ALTITUDE raised safety concerns when combined with ACE inhibitors or ARBs, reducing its market growth scope [2].
  • Amlodipine maintains a favorable safety and efficacy profile, securing its market position despite competition from other calcium channel blockers.

• Regulatory and Patent Dynamics:

  • Patent expirations have eroded monopoly pricing, especially for amlodipine, catalyzing generic entry. Aliskiren’s patent expiry approaches in certain regions could introduce downward pressure on prices.

3. Market Challenges and Opportunities

• COVID-19 Impact: The pandemic disrupted supply chains and delayed non-emergency healthcare access, temporarily affecting prescriptions. However, remote monitoring and telehealth compensated for some demand.

• Regulatory Environment: Stringent safety requirements and evolving hypertension management guidelines influence prescribing patterns and market attractiveness.

• Emerging Markets: Increased healthcare spending in Asia-Pacific and Latin America expands the patient base. Local manufacturing and lower-cost generic options accelerate access in these regions.

• Innovative Formulations: Development of combination pills incorporating aliskiren or amlodipine with other antihypertensives presents growth avenues.

---

Financial Trajectory

1. Revenue Trends

• Amlodipine: Historically, amlodipine ranks among the top antihypertensives globally, with estimated revenues surpassing $1 billion annually. The availability of generics has pressured pricing but maintained volume-based revenue.

• Aliskiren: As a newer entrant, its revenue peaked soon after launch but saw a decline post-2010 due to safety concerns and cautious clinical adoption. Revenue stability now depends on new formulations and markets.

2. Pricing Dynamics

• Amlodipine pricing has plummeted with generic competition, averaging $0.05–$0.10 per pill in developed markets. Despite lower per-unit revenue, high prescription volumes sustain significant aggregate earnings.

• Aliskiren commands higher prices ($1–$3 per dose, depending on formulation and market) initially; however, price erosion occurs with patent expiries and increased competition.

3. Future Revenue Projections

• Growth Potential for Aliskiren:

  • Adoption in combination therapies targeting resistant hypertension.
  • Entry into emerging markets with unmet needs.
  • Development of novel delivery systems may reinvigorate its market share.

• Sustained Dominance of Amlodipine:

  • Continued preference in first-line hypertension management.
  • Market share supported by longstanding clinical evidence.
  • Expanding market through combination formulations and ongoing patent protections in some regions.

4. Impact of Biosimilars and Generics

The burgeoning presence of biosimilars and generics in cardiovascular therapeutics underscores downward pricing pressures, especially on amlodipine, while aliskiren’s market could benefit from patent expirations and strategic repositioning.

---

Future Outlook and Strategic Considerations

• Innovation and Differentiation:
  Companies investing in pharmacokinetic improvements, fixed-dose combinations, and novel formulations will likely unlock new revenue streams. For example, combining aliskiren with amlodipine in single-pill formulations enhances adherence and efficacy.

• Regulatory Approvals and Label Expansion:
  Broader indications and combination therapies could expand market access.

• Market Penetration in Emerging Economies:
  Focused efforts on price-sensitive markets can significantly boost sales, given the increasing prevalence of hypertension.

• Clinical Safety and Efficacy:
  Maintaining a favorable safety profile and demonstrating clinical benefits remain critical to sustain trust and prescribing habits amidst competing therapies.

---

Key Regulatory and Market Factors Influencing the Trajectory

1. Safety Data and Guidelines:
   The safety profile of aliskiren, especially concerning its use with other RAAS inhibitors, remains a limiting factor. Regulatory advisories have tempered its use, influencing sales.

2. Pricing and Patent Strategies:
   Patents extending or strategic licensing can protect revenues. Conversely, patent cliffs necessitate diversification through pipeline expansion or line extensions.

3. Digital and Precision Medicine:
   Integration with telehealth platforms and personalized therapies offers growth avenues, especially for chronic conditions like hypertension.

---

Conclusion

The market dynamics for aliskiren hemifumarate and amlodipine besylate are characterized by divergent trajectories shaped by clinical safety profiles, generic competition, regulatory environments, and burgeoning global demand for antihypertensive therapies. While amlodipine’s entrenched market share benefits from generics and clinical familiarity, aliskiren’s future hinges on strategic repositioning within combination therapies and emerging markets. Both drugs face evolving competition but will continue to serve vital roles in managing hypertension, with innovation and cost-effective formulations driving future growth.

---

Key Takeaways

• Amlodipine besylate remains a dominant, cost-effective antihypertensive with strong global penetration, driven by generic competition and fixed-dose combinations. Its revenues, although pressured by pricing, benefit from high volume sales.

• Aliskiren hemifumarate experienced initial market enthusiasm but has faced safety concerns and limited adoption in some regions. Its future hinges on combination formulations, expanded indications, and emergence in underserved markets.

• Market growth is heavily influenced by increasing hypertension prevalence, aging populations, and rising healthcare expenditure in emerging economies. Innovation in drug formulations and combination therapies will be essential to sustain revenue.

• Regulatory landscapes shape market access; safety concerns have moderated usage, especially for aliskiren, necessitating strategic repositioning.

• Competitive pressures necessitate ongoing R&D, strategic licensing, and market diversification to capitalize on the expanding global cardiovascular disease burden.

---

FAQs

1. How is the patent landscape impacting the market for aliskiren hemifumarate?
Patent protections delayed generic competition initially, but impending patent expiries in key markets like the US and Europe are expected to open opportunities for generic manufacturers, exerting downward pressure on prices and impacting revenue streams.

2. Why has amlodipine besylate maintained such a high market share despite the availability of generics?
Its proven efficacy, safety, long half-life, and minimal adverse effects have cemented its position. The affordability of generics further sustains high prescription volumes, securing sustained market share.

3. What impact did clinical trials like ALTITUDE have on aliskiren's market?
They raised safety concerns, particularly regarding increased risks of hyperkalemia and renal impairment when combined with ACE inhibitors or ARBs, leading to more cautious prescribing and limited growth potential.

4. Are fixed-dose combinations more promising for these drugs' financial prospects?
Yes. FDCs improve patient compliance, facilitate combination therapies, and extend patent life. Both aliskiren and amlodipine are increasingly formulated in such combinations, bolstering market growth.

5. What are the key opportunities for growth in emerging markets?
Expanding access through lower-cost generics, addressing unmet needs for resistant hypertension, and leveraging local manufacturing will be critical for sustained revenue growth in regions like Asia-Pacific and Latin America.

---

Sources
[1] WHO Global Health Observatory, 2022.
[2] Parving, H. H., et al., "ALTITUDE trial safety findings," The New England Journal of Medicine, 2012.