AMTURNIDE Drug Patent Profile

Which patents cover Amturnide, and when can generic versions of Amturnide launch?

Amturnide is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in AMTURNIDE is aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide profile page.

Summary for AMTURNIDE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4
DailyMed Link:	AMTURNIDE at DailyMed

US Patents and Regulatory Information for AMTURNIDE

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	200045-001	Dec 21, 2010		DISCN	No	No
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-004	Dec 21, 2010		DISCN	No	No
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-002	Dec 21, 2010		DISCN	No	No
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-003	Dec 21, 2010		DISCN	No	No
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-005	Dec 21, 2010		DISCN	No	No

Expired US Patents for AMTURNIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-003	Dec 21, 2010	5,559,111
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-001	Dec 21, 2010	5,559,111
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-004	Dec 21, 2010	8,183,295
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-004	Dec 21, 2010	5,559,111
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-005	Dec 21, 2010	8,618,174
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-004	Dec 21, 2010	8,618,174
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-005	Dec 21, 2010	8,183,295

International Patents for AMTURNIDE

See the table below for patents covering AMTURNIDE around the world.

Country	Patent Number	Title	Estimated Expiration
Slovakia	287881
Australia	2368002
Japan	H0881430	NOVEL DELTA-AMINO-GAMMA-HYDROXY-OMEGA-ARYLALKANAMIDE
Austria	520417
New Zealand	536555	Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic
Japan	2009235107	SYNERGISTIC COMBINATION COMPRISING RENIN INHIBITOR FOR CARDIOVASCULAR DISEASE
Denmark	1341533

Supplementary Protection Certificates for AMTURNIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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
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	C00678503/01	Switzerland		PRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007
1602370	09C0020	France		PRODUCT NAME: COMBINAISON COMRENANT L’ALISKIREN SOUS FORME DE BAE LIBRE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, ET L’HYDROCHLOROTHIAZIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/08/491/001 DU 20090116; REGISTRATION NO/DATE AT EEC: 58935 01-04 DU 20081028
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

AMTURNIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amturnide

Introduction

Amturnide, a triple-combination pill, was approved by the FDA on December 21, 2010, for the treatment of high blood pressure in patients whose blood pressure is not adequately controlled with any two of its individual components. This article delves into the market dynamics and financial trajectory of Amturnide, highlighting its key features, market performance, and the factors that influenced its commercial success.

Market Need and Target Population

High blood pressure is a prevalent condition that often requires multiple medications to manage. Up to 85% of patients may need more than one medication to reach their blood pressure goals, and some may require three or more medications[1]. Amturnide was designed to address this complex need by combining the direct renin inhibitor aliskiren (Tekturna), the calcium channel blocker amlodipine, and the diuretic hydrochlorothiazide (HCTZ) in a single pill.

Clinical Efficacy

The FDA approval of Amturnide was based on a double-blind, active-controlled study that demonstrated significantly greater reductions in blood pressure compared to all dual combinations of its components. The study involved 1,181 patients and showed that Amturnide provided additional reductions in systolic and diastolic blood pressure compared to the dual combinations[1].

Market Reception and Adoption

Upon its approval, Amturnide was seen as an important treatment option for high blood pressure patients who had not reached their blood pressure goals with dual therapy. It was the third high blood pressure treatment to combine three drugs in a single pill, offering a convenient and effective solution for patients requiring multiple medications[1].

Financial Performance

Although specific financial data for Amturnide alone is not readily available, the overall financial performance of Novartis Pharmaceuticals Corporation during the period of Amturnide's introduction can provide some context. In 2010, the year Amturnide was approved, Novartis reported net sales of $50.624 billion and an operating income from continuing operations of $10.153 billion[2].

Market Growth and Projections

The aliskiren market, which includes Amturnide, has been growing at a moderate pace. The increasing effectiveness of aliskiren in controlling hypertension, its ability to be combined with all classes of current antihypertensive drugs, and government initiatives to improve health awareness have driven market growth. However, the high cost of the components and production constraints have limited the market's potential[3].

Challenges and Discontinuation

Despite its clinical efficacy, Amturnide faced several challenges. The high cost of the medication and production issues were significant hurdles. Additionally, the drug's complex formulation and the need for careful patient selection may have limited its adoption. As of the latest information, Amturnide has been discontinued from the market[4].

Expert Insights

"Some patients require three or more medications to help manage their high blood pressure, which can be challenging and inconvenient," said Alan H. Gradman, M.D., Professor of Medicine at Temple University School of Medicine. "The approval of Amturnide provided physicians with an effective treatment option that combines the benefits of the only approved direct renin inhibitor, a calcium channel blocker, and a diuretic in one pill, while offering blood pressure reductions greater than two drugs alone."[1]

Market Segmentation and Distribution

The aliskiren market, including Amturnide, is segmented based on type (150 mg and 300 mg tablets), application (hospitals, drug stores, and others), and geography. However, the discontinuation of Amturnide means it is no longer a part of these market segments[3].

Key Takeaways

• Clinical Efficacy: Amturnide demonstrated significant reductions in blood pressure compared to dual combinations of its components.
• Market Need: Addressed the need for multiple medications in high blood pressure management.
• Financial Performance: Part of Novartis's broader financial landscape, but specific data is not available.
• Challenges: High cost, production constraints, and complex formulation led to its discontinuation.
• Market Growth: The aliskiren market continues to grow, driven by effectiveness and government initiatives.

FAQs

1. What is Amturnide? Amturnide is a triple-combination pill that combines aliskiren (a direct renin inhibitor), amlodipine (a calcium channel blocker), and hydrochlorothiazide (a diuretic) to treat high blood pressure.

2. Why was Amturnide approved? Amturnide was approved by the FDA for patients whose blood pressure is not adequately controlled with any two of its individual components, offering greater reductions in blood pressure compared to dual combinations.

3. What were the challenges faced by Amturnide? Amturnide faced challenges such as high production costs, complex formulation, and limited adoption due to these factors.

4. Is Amturnide still available on the market? No, Amturnide has been discontinued from the market.

5. What are the key drivers of the aliskiren market? The key drivers include increasing effectiveness in controlling hypertension, the ability to combine with other antihypertensive drugs, and government initiatives to improve health awareness.

Cited Sources:

1. Novartis Press Release - "Novartis Gains FDA Approval for Amturnide™, a Triple-Combination Pill to Treat High Blood Pressure Patients Uncontrolled on Two Medications"[1].
2. Novartis 20-F 2014 - Financial Reporting and Market Data[2].
3. Verified Market Research - "Aliskiren Market Size, Share, Scope, Trends, Opportunities & Forecast"[3].
4. Drugs.com - "Amturnide FDA Approval History"[4].