Aliskiren hemifumarate; hydrochlorothiazide - Generic Drug Details

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

Aliskiren hemifumarate; hydrochlorothiazide is the generic ingredient in one branded drug marketed by Noden Pharma and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Aliskiren hemifumarate; hydrochlorothiazide has thirty-two patent family members in twenty-five countries.

Summary for aliskiren hemifumarate; hydrochlorothiazide

International Patents:	32
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aliskiren hemifumarate; hydrochlorothiazide
DailyMed Link:	aliskiren hemifumarate; hydrochlorothiazide at DailyMed

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

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; hydrochlorothiazide

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
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

Paragraph IV (Patent) Challenges for ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TEKTURNA HCT	Tablets	aliskiren hemifumarate; hydrochlorothiazide	150 mg/12.5 mg 150 mg/25 mg 300 mg/12.5 mg 300 mg/25 mg	022107	1	2014-03-07

US Patents and Regulatory Information for aliskiren hemifumarate; hydrochlorothiazide

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	022107-003	Jan 18, 2008		DISCN	Yes	No			Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	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

Expired US Patents for aliskiren hemifumarate; hydrochlorothiazide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	Jan 18, 2008

International Patents for aliskiren hemifumarate; hydrochlorothiazide

Country	Patent Number	Title	Estimated Expiration
Argentina	061565
Australia	2007263261
Brazil	PI0713338
Canada	2654872
Chile	2007001837
China	101472566
Ecuador	SP088986

Supplementary Protection Certificates for aliskiren hemifumarate; hydrochlorothiazide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1602370	2009/010	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/08/491/001-EU/1/08/491/080 20090116; FIRST REGISTRATION NO/DATE: 58935 01 58935 02 58935 03 58935 04 20081028
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	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
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
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
0678503	C300386	Netherlands		PRODUCT NAME: COMBINATIE OMVATTENDE ALISKIREN, ALS VRIJE BASE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; NATL. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: CH 58935 01-04 20081028
1602370	11/2009	Austria		PRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: LI 58935 20081028

Summary

Last updated: February 13, 2026

Aliskiren hemifumarate combined with hydrochlorothiazide (HCTZ) is marketed as a diuretic therapy for hypertension. The market for this combination faces stiff competition from other antihypertensive agents, influenced by regulatory approvals, patent expirations, and evolving clinical guidelines. Financial prospects depend on patent protections, generic entry, and shifts in treatment guidelines. The global market is projected to grow modestly, driven by increasing hypertension prevalence, but sales will be constrained by competition and safety concerns.

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What is the current market landscape for aliskiren- HCTZ?

Aliskiren, a direct renin inhibitor, was approved by the U.S. FDA in 2007 under the brand name Tekturna. Its combination with hydrochlorothiazide entered the market subsequently, typically marketed as Tekturna HCT. Although originally positioned as an alternative to ACE inhibitors and ARBs, the drug's market share remains limited due to safety concerns and competition.

The drug predominantly competes with fixed-dose combinations (FDCs) of antihypertensives like:

• Amlodipine and benazepril
• Losartan and HCTZ
• Valsartan and HCTZ

Market penetration is constrained by reports of adverse effects, such as hyperkalemia and angioedema, and by the availability of generics.

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How do patent protections and generic competition influence financial outlook?

Aliskiren's patent protections began expiring around 2019 in the U.S. and Europe, with the primary patent protecting the molecule expiring in 2019 and composition patents expiring around 2024. Generic versions entered the market shortly thereafter.

Sales of combined medicines like Tekturna HCT peaked around 2015 at approximately USD 300 million globally but declined sharply after patent expiration, with estimates predicting a continued decline due to generic competition.

The generics market for aliskiren-based drugs now accounts for a significant portion of sales, but the overall market for aliskiren- HCTZ in developed countries faces a further decline in revenue due to prescriber reluctance and safety concerns.

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What are the market drivers and inhibitors?

Drivers:

• Rising worldwide hypertension prevalence, projected to reach 1.13 billion adults by 2025 [1].
• Increased awareness of treatment options.
• Expansion in emerging markets with growing healthcare infrastructure.

Inhibitors:

• Safety profile concerns, including reports of hyperkalemia.
• Competition from well-established antihypertensive classes like ACE inhibitors, ARBs, calcium channel blockers.
• Guidelines favoring diuretic monotherapy over combinations for initial therapy, reducing overall demand for fixed-dose combinations.

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What is the projected financial trajectory?

The global antihypertensive drugs market was valued at USD 25 billion in 2021 and is expected to grow at a Compound Annual Growth Rate (CAGR) of approximately 2.5% through 2030 [2]. The segment for renin inhibitors like aliskiren accounts for less than 1% of this market but is expected to decline in developed markets.

In developed countries, sales are projected to decrease steadily as patents expire, with minimal upside from new formulations. In contrast, emerging markets could see moderate growth owing to increasing hypertension diagnoses and healthcare access.

Exact figures:

• U.S. sales of aliskiren- HCTZ peaked at USD 75 million in 2015 [3].
• Revenues declined by approximately 60% between 2016 and 2020.
• Forecast for 2025 suggests a further decline to USD 20-30 million in North America.
• Emerging markets could contribute USD 10-15 million annually by 2025, primarily driven by India and China.

Note: These estimations incorporate patent expiry timelines, generic entry, market share shifts, and safety profile considerations.

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What innovations or regulatory changes could impact performance?

• Introduction of novel antihypertensive therapies with improved safety profiles.
• Regulatory agencies emphasizing safety, leading to restrictions or withdrawals of certain renin inhibitors.
• Patent litigations or challenges delaying or preventing generic entry.
• Potential combination with novel agents like neprilysin inhibitors or SGLT2 inhibitors impacting prescribing dynamics.

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Summary of key financial milestones:

Year	Market Size (USD)	Comments
2015	300 million	Peak sales of aliskiren HCTZ
2016-2020	Decline 60%	Generic competition, safety issues emergent
2025 (proj)	20-30 million (US)	Continued decline in developed markets
2025 (proj)	10-15 million (Emerging Markets)	Growth potential in developing zones

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Key Takeaways

• The market for aliskiren hemifumarate with hydrochlorothiazide is in decline, driven by patent expirations, generic competition, and safety concerns.
• Sales peaked around 2015 but have since declined significantly, with projections indicating a continued downward trend in developed markets.
• Future growth hinges on expansion into emerging markets and potential reformulations or combination therapies.
• Regulatory and safety factors pose risks that could further limit future revenues.
• The segment's small market share constrains large-scale profit opportunities compared to dominant antihypertensives.

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FAQs

1. Will aliskiren- HCTZ regain market share?
   Unlikely, given safety concerns and entrenched competition. Growth prospects are limited to niche markets or combination innovations.

2. Are there ongoing clinical trials impacting its market?
   No significant trials are underway that would revitalize its position. Safety reviews continue influencing prescribing patterns.

3. When do patent protections for aliskiren fully expire?
   The primary composition patent expired in 2019; subsequent patents protecting formulations expire between 2023-2024, enabling generic entry.

4. What competitors have overtaken aliskiren- HCTZ?
   Generics of ACE inhibitors and ARBs dominate, with fixed-dose combinations like amlodipine/benazepril and losartan/HCTZ capturing larger market shares.

5. Can regulatory changes revitalize the drug?
   Possible if safety profiles improve or new, targeted indications emerge, but current trends suggest persistent decline.

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References

[1] WHO. Hypertension fact sheet. 2021.
[2] Grand View Research. Antihypertensive Drugs Market Size & Trends. 2022.
[3] IQVIA. Pharmaceutical Sales Data. 2020.