ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - Generic Drug Details

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

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	022107-004	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	022107-003	Jan 18, 2008		DISCN	Yes	No			Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	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	022107-003	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	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	022107-002	Jan 18, 2008

International Patents for ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

Country	Patent Number	Title	Estimated Expiration
Guatemala	200800297	FORMULACIONES GALENICAS DE ALISQUIRENO E HIDROCLOROTIAZIDA
United Kingdom	0612540
Brazil	PI0713338	formulaÇÕes galÊnicas de compostos orgÂnicos
Morocco	30527	FORMES GALENIQUES ASSOCIANT ALISKIRENE ET HYDROCHLOROTHIAZIDE
Spain	2704979
Peru	20080373	FORMULACIONES DE ALISQUIRENO E HIDROCLOROTIAZIDA

Supplementary Protection Certificates for ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0678503	C00678503/02	Switzerland		PRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008
0678503	07C0055	France		PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
1602370	SPC/GB09/024	United Kingdom		PRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
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
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

ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aliskiren Hemifumarate and Hydrochlorothiazide

Introduction to Aliskiren and Hydrochlorothiazide

Aliskiren, a non-peptide direct renin inhibitor, and hydrochlorothiazide (HCTZ), a thiazide diuretic, are combined in a single-pill formulation to treat hypertension. This combination, known as Tekturna HCT or Rasilez HCT, has shown significant efficacy in reducing blood pressure compared to monotherapy with either component alone[2][5].

Market Size and Growth

The global aliskiren market is growing at a moderate pace, driven by several key factors. The increasing effectiveness of aliskiren in controlling hypertension, its ability to be combined with all classes of current antihypertensive drugs, and the rise in health awareness are significant drivers. Additionally, government initiatives and the demand for personalized medicines contribute to the market growth[3].

Market Segmentation

The aliskiren market is segmented based on type, application, and geography.

• Type: The market includes 150 mg and 300 mg tablets of aliskiren, with other formulations also available[3].
• Application: The primary applications are in hospitals and drug stores, with other healthcare settings also utilizing these medications[3].
• Geography: The market is classified into North America, Europe, Asia Pacific, and the rest of the world. North America is expected to grow at the highest CAGR during the forecast period due to the presence of major players in the market[3].

Efficacy and Clinical Outcomes

Clinical trials have demonstrated the efficacy of the aliskiren/HCTZ combination in reducing blood pressure. In double-blind, 8-week clinical trials, this combination showed greater reductions in mean sitting systolic and diastolic blood pressure compared to placebo, aliskiren monotherapy, and HCTZ monotherapy. Long-term studies up to one year have also shown sustained blood pressure control with this combination[2].

Pharmacokinetics

The pharmacokinetic profiles of aliskiren and HCTZ in the fixed-dose combination tablets are bioequivalent to those of the individual components. However, co-administration can result in a decrease in the Cmax of both drugs, although this is considered clinically unimportant. Food intake significantly reduces the bioavailability of aliskiren but has no effect on HCTZ[1].

Safety and Adverse Reactions

While the aliskiren/HCTZ combination is generally well-tolerated, there are notable safety concerns. The ALTITUDE trial, which evaluated aliskiren in patients with type 2 diabetes and renal disease, was terminated early due to increased risks of renal impairment, hypotension, and hyperkalemia in patients treated with aliskiren compared to placebo. These findings led to new warnings and contraindications for aliskiren use in certain patient populations[4].

Financial Trajectory

Revenue Growth

The aliskiren market is expected to grow significantly over the forecast period, driven by its increasing adoption and the expanding patient base. The market's revenue growth is also influenced by the rising demand for effective antihypertensive treatments and the integration of aliskiren into various treatment regimens[3].

Cost and Production Constraints

Despite the growth potential, the market faces constraints such as the high cost of the components of aliskiren medicines and production challenges. These factors can limit the accessibility and affordability of these medications, particularly in regions with limited healthcare resources[3].

Competitive Landscape

The global aliskiren market is competitive, with several major players involved. Key companies include Novartis, Noden Pharma, LGM Pharma, Cayman, Vitae-GSK, Daiichi Sankyo, Merck-Frost, Mitsubishi-Tanabe, Takeda, and Cadila Healthcare. These companies are driving innovation and market expansion through strategic developments and increased market share[3].

Regulatory Environment

Regulatory bodies such as the FDA have played a crucial role in shaping the market dynamics of aliskiren. The FDA has issued warnings and contraindications based on clinical trial data, which has impacted the prescribing patterns and patient safety profiles of these medications[4].

Key Takeaways

• Efficacy: The aliskiren/HCTZ combination is highly effective in reducing blood pressure and is superior to monotherapy with either component.
• Market Growth: The global aliskiren market is growing, driven by increasing effectiveness, government initiatives, and rising health awareness.
• Safety Concerns: The combination is generally well-tolerated but has significant safety concerns, particularly in patients with type 2 diabetes and renal disease.
• Financial Trajectory: The market is expected to grow, but faces constraints such as high production costs and limited accessibility.
• Competitive Landscape: The market is competitive with several major pharmaceutical companies involved.

FAQs

What is the primary use of the aliskiren/HCTZ combination?

The primary use of the aliskiren/HCTZ combination is for the treatment of hypertension, particularly in patients who are unlikely to achieve blood pressure control with a single agent[1][2].

What are the key drivers of the global aliskiren market?

The key drivers include the increasing effectiveness in controlling hypertension, the ability to combine aliskiren with all classes of current antihypertensive drugs, and the rise in health awareness and government initiatives[3].

What are the safety concerns associated with aliskiren use?

Aliskiren use is associated with increased risks of renal impairment, hypotension, and hyperkalemia, particularly in patients with type 2 diabetes and renal disease[4].

How does the pharmacokinetic profile of the aliskiren/HCTZ combination compare to individual components?

The pharmacokinetic profiles of aliskiren and HCTZ in the fixed-dose combination tablets are bioequivalent to those of the individual components, although co-administration can result in a decrease in the Cmax of both drugs[1].

What are the major players in the global aliskiren market?

Major players include Novartis, Noden Pharma, LGM Pharma, Cayman, Vitae-GSK, Daiichi Sankyo, Merck-Frost, Mitsubishi-Tanabe, Takeda, and Cadila Healthcare[3].

Sources

1. Australian Public Assessment Report for Aliskiren (as hemifumarate) and Hydrochlorothiazide. Novartis Pharmaceuticals Australia Pty Ltd, 2010.
2. Aliskiren/hydrochlorothiazide combination: in mild to moderate hypertension. PubMed, 2009.
3. Aliskiren Market Size, Share, Scope, Trends, Opportunities & Forecast. Verified Market Research.
4. New Warning and Contraindication for blood pressure medicines containing aliskiren. FDA, 2021.
5. Tekturna HCT (aliskiren and hydrochlorothiazide) tablets label. FDA, 2013.