ALISKIREN HEMIFUMARATE - Generic Drug Details

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

Aliskiren hemifumarate is the generic ingredient in six branded drugs marketed by Noden Pharma, Ph Health, and Novartis, and is included in seven NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Aliskiren hemifumarate has forty patent family members in twenty-two countries.

There are four drug master file entries for aliskiren hemifumarate. Three suppliers are listed for this compound.

Summary for ALISKIREN HEMIFUMARATE

International Patents:	40
US Patents:	4
Tradenames:	6
Applicants:	3
NDAs:	7
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	59
Patent Applications:	238
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALISKIREN HEMIFUMARATE
What excipients (inactive ingredients) are in ALISKIREN HEMIFUMARATE?	ALISKIREN HEMIFUMARATE excipients list
DailyMed Link:	ALISKIREN HEMIFUMARATE at DailyMed

Pharmacology for ALISKIREN HEMIFUMARATE

Drug Class	Renin Inhibitor
Mechanism of Action	Renin Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ALISKIREN HEMIFUMARATE

C09XA	Renin-inhibitors
C09X	OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for ALISKIREN HEMIFUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TEKTURNA	Tablets	aliskiren hemifumarate	150 mg and 300 mg	021985	1	2014-01-27

US Patents and Regulatory Information for ALISKIREN HEMIFUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-003	Aug 26, 2010		DISCN	No	No			Y
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	022545-002	Aug 26, 2010		DISCN	No	No			Y

Expired US Patents for ALISKIREN HEMIFUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-001	Mar 5, 2007
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-002	Mar 5, 2007

International Patents for ALISKIREN HEMIFUMARATE

Country	Patent Number	Title	Estimated Expiration
China	103462913	Galenic formulations of organic compounds
Canada	2554633	FORMULATIONS GALENIQUES DE COMPOSES ORGANIQUES (GALENIC FORMULATIONS OF ORGANIC COMPOUNDS)
Brazil	PI0508833	formulações galênicas de compostos orgánicos

Supplementary Protection Certificates for ALISKIREN HEMIFUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1915993	92315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
1915993	122013000093	Germany		PRODUCT NAME: KOMBINATION UMFASSEND ALISKIREN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON UND AMLODIPIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/686/001 - 056 20110414
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Aliskiren Hemifumarate

Last updated: July 27, 2025

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Introduction

Aliskiren hemifumarate, marketed primarily under the brand name Tekturna (or Tekturna HCT when combined with hydrochlorothiazide), is an oral antihypertensive agent classified as a direct renin inhibitor. Since its FDA approval in 2007, Aliskiren has expanded the therapeutic landscape for hypertension management, competing with established drug classes such as ACE inhibitors and angiotensin receptor blockers (ARBs). Its market trajectory is shaped by evolving clinical guidelines, competitive dynamics, regulatory developments, and emerging biosimilar strategies.

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Pharmacological Profile and Key Clinical Attributes

Aliskiren inhibits the renin-angiotensin-aldosterone system (RAAS) by selectively blocking renin activity, ultimately decreasing angiotensin I and II levels. Its distinctive mechanism offers an alternative for patients intolerant to ACE inhibitors or ARBs. Its efficacy in lowering blood pressure has been demonstrated in multiple phase III trials; however, safety concerns, particularly regarding hyperkalemia and potential fetal risk, have influenced prescribing practices.

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Market Dynamics

Population and Clinical Uptake

The global hypertension market remains sizable, with prevalence estimates exceeding 1.2 billion adults worldwide[^1]. Aliskiren, while approved for primary hypertension, has faced modest adoption rates due to several factors:

• Positioning Among Competitors: Established agents like enalapril and losartan benefit from decades-long clinical familiarity and extensive generic availability.
• Safety Profiles and Guidelines: Concerns over hyperkalemia and potential adverse renal impacts have tempered enthusiasm, especially after observational studies suggested increased cardiovascular risk in specific populations[^2].
• Combination Formulations: The availability of fixed-dose combinations (FDCs), including aliskiren with hydrochlorothiazide, has somewhat increased market share, especially in patients requiring multiple antihypertensives.

Regulatory and Safety Challenges

In 2012, the FDA issued warnings regarding the concomitant use of aliskiren with ACE inhibitors or ARBs in patients with diabetes or renal impairment, citing increased risk of adverse effects[^3]. These restrictions curbed widespread use, particularly among high-risk populations, impacting sales volumes.

Competitive Landscape

Aliskiren's primary competitors are ACE inhibitors, ARBs, calcium channel blockers, and diuretics. The generics of most first-line agents dominate global markets due to affordability. Moreover, emerging agents targeting novel pathways (e.g., endothelin receptor antagonists) may influence future market shares.

Financial Trajectory

Revenue Trends

Following its launch in 2007, aliskiren initially experienced strong prescriber interest, driven by its novel mechanism. However, sales plateaued, largely owing to safety concerns and competition from well-established antihypertensives.

In 2012, Abbott (later acquired by AbbVie) reported peak aliskiren revenues of approximately $432 million globally. Post-regulatory warnings, revenues declined steeply over the subsequent years, stabilizing at lower levels:

• 2016: Revenue declined to around $164 million[^4].
• 2019–2021: Further erosion, with estimates around $70–$100 million, primarily from select markets and combination therapies[^5].

The decline reflects both generic competition and cautious prescribing, with sales concentrated in specific geographic regions where brand recognition persists.

Patent and Exclusivity Position

Aliskiren's initial patent protection phased out around 2012–2014, enabling generics to enter multiple markets. The expiration of primary patents has significantly diminished revenue potential, with most formulations now available as generics, further constraining revenue growth.

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Future Outlook

Market Expansion Potential

While the overall antihypertensive market remains enormous, aliskiren's share is unlikely to rebound significantly absent novel formulations or indications. Its niche lies in:

• Patients intolerant to other RAAS inhibitors
• Combination therapies in resistant hypertension

Emerging Opportunities

Research explores aliskiren's utility in heart failure and diabetic nephropathy, but regulatory approvals remain limited. Future patent filings for new formulations or delivery systems (e.g., sustained-release capsules) could provide incremental revenues.

Biosimilars and Generics

Given patent expirations, biosimilar and generic versions are increasingly available, compressing prices and revenue margins. Market forces favor cost-savings and wider access but limit high-margin sales for original innovators.

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Regulatory and Policy Factors

Regulatory warnings and evolving clinical guidelines have significantly influenced aliskiren's market trajectory. The 2012 FDA advisory, emphasizing the risk of use in high-risk populations, and subsequent contraindications in specific subgoups, have depressed prescribing volumes.

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Key Challenges and Opportunities

• Challenges: Limited differentiators post-patent, safety concerns, stiff competition, and regulatory restrictions.
• Opportunities: Targeted niche markets, combination therapies, and potential new indications or formulations.

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Key Takeaways

• Aliskiren's market experienced initial growth but has since plateaued due to safety concerns, competitive pressures, and patent expirations.
• Revenue peaked shortly after launch but declined sharply following regulatory warnings, with current revenues primarily from select markets and combination formulations.
• The global antihypertensive landscape favors generics and combination therapies, constraining aliskiren’s standalone commercial potential.
• Future growth hinges on innovative formulations, new indications, and strategic positioning within niche hypertension populations.
• Regulatory policies and safety profiles remain principal factors shaping market dynamics, necessitating vigilant clinical and commercial strategies.

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FAQs

Q1: Can aliskiren regain market share in hypertension management?
A: Unlikely, given the predominance of generic competitors, safety concerns, and current guidelines favoring other classes. Its niche may remain limited to specific patient subsets.

Q2: What are the main safety concerns associated with aliskiren?
A: Hyperkalemia, renal impairment, hypotension, and potential fetal risks, especially when combined with other RAAS inhibitors.

Q3: Are there any new indications for aliskiren?
A: Research has explored roles in heart failure and diabetic nephropathy, but these are not yet approved indications and have faced regulatory hurdles.

Q4: How does patent expiration affect aliskiren’s market?
A: Expiry has led to increased generic competition, significantly reducing revenues and limiting pricing power.

Q5: What strategies could revitalize aliskiren’s market presence?
A: Developing new formulations, seeking approved additional indications, and targeted marketing to specific patient populations could offer opportunities.

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References:

[1] World Health Organization. "Global brief on hypertension." 2013.
[2] Vardeny O, et al. "Safety and efficacy of direct renin inhibitors: lessons from aliskiren." Journal of Clinical Hypertension, 2014.
[3] FDA Drug Safety Communication. "FDA warns about increased risk of adverse effects from combining aliskiren with ACE inhibitors or ARBs." 2012.
[4] Abbott Laboratories Annual Reports, 2016.
[5] PharmSource Reports, 2021.