Aliskiren hemifumarate - Generic Drug Details

What are the generic drug 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, Lxo Ireland, 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:	4
NDAs:	7
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	59
Patent Applications:	260
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
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	Jan 18, 2008		DISCN	Yes	No			Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	Jan 18, 2008		DISCN	Yes	No			Y
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-002	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	022545-002	Aug 26, 2010		DISCN	No	No			Y
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-001	Sep 16, 2009		DISCN	No	No			Y

International Patents for aliskiren hemifumarate

Country	Patent Number	Title	Estimated Expiration
Argentina	048431	FORMULACIONES GALENICAS DE COMPUESTOS ORGANICOS
Australia	2005224010	Galenic formulations of organic compounds
Australia	2009202069	Galenic formulations of organic compounds
Brazil	PI0508833	formulações galênicas de compostos orgánicos
Canada	2554633	FORMULATIONS GALENIQUES DE COMPOSES ORGANIQUES (GALENIC FORMULATIONS OF ORGANIC COMPOUNDS)
China	103462913	Galenic formulations of organic compounds

Supplementary Protection Certificates for aliskiren hemifumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0678503	C00678503/04	Switzerland		PRODUCT NAME: ALISKIREN + AMLODIPIN; REGISTRATION NO/DATE: SWISSMEDIC 61454 05.07.2011
1507558	1290018-9	Sweden		PRODUCT NAME: ALISKIREN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, AMLODIPIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH HYDROKLORTIAZID ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; NAT. REGISTRATIPON NO/DATE: EU/1/11/730 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
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
1507558	CR 2012 00018	Denmark		PRODUCT NAME: ALISKIREN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, AMLODIPIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG HYDROCHLORTHIAZID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: EU/1/11/730/001-060 20111122; FIRST REG. NO/DATE: CH 61678 01-05 20110705
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

Market Dynamics and Financial Trajectory for Aliskiren Hemifumarate

Last updated: February 20, 2026

What are the key market drivers for Aliskiren Hemifumarate?

Aliskiren Hemifumarate, a direct renin inhibitor approved for hypertension, faces a competitive landscape dominated by ACE inhibitors and ARBs. The drug's growth depends on factors such as increasing worldwide hypertension prevalence, the launch of biosimilars or generics, regulatory acceptance, and evolving clinical guidelines favoring specific patient populations.

World hypertension prevalence reached approximately 1.28 billion in 2019 and is projected to grow annually at 2-3%. Monotherapy adoption remains high, but combination therapies with other antihypertentives may limit Aliskiren's standalone market share due to safety concerns. As of 2022, Aliskiren accounted for approximately 1% of the global antihypertensive drug market, indicating limited penetration.

What is the regulatory status and pipeline for Aliskiren Hemifumarate?

Currently, Aliskiren is marketed in key regions including the US, Europe, Japan, and select Asian markets. The FDA approved it in 2007, with the European Medicines Agency (EMA) approval following in 2007. Its patent protection expired or is expiring in various jurisdictions from 2023 onward, paving the way for generic competition.

No recent regulatory submissions or new indications for Aliskiren Hemifumarate are publicly announced. The company’s pipeline may include combination formulations, but data remains confidential.

How does competitive positioning impact financial prospects?

Aliskiren faces intense competition from ACE inhibitors such as Lisinopril and Enalapril, and ARBs like Losartan and Valsartan. Some large pharmaceutical firms have discontinued or deprioritized its development due to safety concerns including hyperkalemia, renal impairment, and hypotension in certain patients.

Generic entry will exert downward pressure on list prices. Market penetration will decline unless new formulations or indications emerge. Companies leveraging patent extensions or formulation innovations could sustain revenues longer.

What are the revenue projections and profit considerations?

Revenue estimates for Aliskiren Hemifumarate in 2023 range between $50 million and $125 million globally, with a declining trend forecasted over the next five years due to generic competition and market saturation.

Profit margins depend heavily on manufacturing costs and licensing agreements. With patent expiry-induced price erosion, gross margins are likely to decrease from approximately 75% to below 50%.

What are the market expansion opportunities?

Market growth avenues include:

• Expanding into emerging markets where hypertension diagnoses rise rapidly and drug access improves.
• Developing fixed-dose combination pills that enhance patient compliance.
• Exploring novel indications such as diabetic nephropathy, subject to further clinical validation.

Global expansion prospects are constrained by pricing pressures and existing competition but remain viable if companies innovate formulations or establish strategic partnerships.

How will regulatory and policy environments influence future market dynamics?

Regulatory agencies increasingly favor personalized medicine and safety data transparency. Compliance costs for new formulations or combination therapies are substantial but can lead to differentiated products.

Price control policies, especially in Europe and parts of Asia, may cap reimbursement levels, reducing profitability. Certain regions incentivize generic substitution, accelerating market entry and volume decline.

What are the key risks impacting the financial trajectory?

• Market share erosion due to generic competition.
• Regulatory bans or safety concerns linked to adverse effects.
• Delays or failures in pipeline candidate development, or lack of new formulations.
• Pricing restrictions driven by healthcare systems.

Summary Table: Market and Financial Overview

Factor	Impact	Data Points
Market Penetration	Limited, 1% of antihypertensive market	Estimated $50m–$125m 2023 revenue
Patent Expiry	2023+, opens market to generics	Patent expiration dates vary by jurisdiction
Competition	Strong; ACE inhibitors, ARBs, generics	List of top competitors includes Lisinopril, Enalapril, Losartan
Regulatory Scope	Approved in multiple regions	2007 FDA and EMA approvals
Revenue Trend	Declining	Projected CAGR of -10% to -15% over next 5 years

Key Takeaways

• Aliskiren Hemifumarate's current market penetration remains modest.
• The patent expiry beginning in 2023 poses a significant threat to revenue streams.
• Competition from generics and established drug classes limits growth prospects.
• Expansion into emerging markets and new formulations hold potential but face regulatory and pricing challenges.
• Overall, the drug's financial trajectory is expected to decline unless new indications or unique formulations are successfully developed.

Frequently Asked Questions

1. When does Aliskiren Hemifumarate’s patent protection expire in major markets?
Patent protection varies by jurisdiction, generally ending between 2023 and 2025, enabling generic entry.

2. How significant is the impact of generic competition on Aliskiren’s revenue?
Generics can reduce prices by 60-80%, leading to substantial revenue decline and shrinking market share.

3. Are there any ongoing clinical trials for new indications?
No publicly available trials target new indications; efforts focus primarily on combination therapies and formulations.

4. How does Aliskiren compare to ARBs in safety and efficacy?
Clinical evidence suggests a comparable efficacy profile but with safety concerns such as hyperkalemia and renal impairment limiting its use.

5. What strategies can sustain Aliskiren’s market presence?
Developing combination pills, expanding into emerging markets, and pursuing novel indications are primary strategies.

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References

[1] World Health Organization. (2021). Hypertension. Retrieved from https://www.who.int/news-room/fact-sheets/detail/hypertension
[2] U.S. Food and Drug Administration. (2007). FDA approval for Aliskiren.
[3] European Medicines Agency. (2007). Aliskiren marketing authorization.
[4] Johnson & Johnson. (2022). Annual Report.
[5] MarketWatch. (2023). Global antihypertensives market report.