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EXFORGE HCT Drug Patent Profile

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Which patents cover Exforge Hct, and what generic alternatives are available?

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

The generic ingredient in EXFORGE HCT is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

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Summary for EXFORGE HCT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	15
Drug Prices:	Drug price information for EXFORGE HCT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EXFORGE HCT
What excipients (inactive ingredients) are in EXFORGE HCT?	EXFORGE HCT excipients list
DailyMed Link:	EXFORGE HCT at DailyMed

Drug patent expirations by year for EXFORGE HCT

Recent Clinical Trials for EXFORGE HCT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
International Bio service	Phase 1
Novartis Pharmaceuticals	Phase 4
Hanlim Pharm. Co., Ltd.	Phase 1

See all EXFORGE HCT clinical trials

Pharmacology for EXFORGE HCT

Drug Class	Angiotensin 2 Receptor Blocker Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors
Physiological Effect	Increased Diuresis

Paragraph IV (Patent) Challenges for EXFORGE HCT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXFORGE HCT	Tablets	amlodipine besylate; hydrochlorothiazide; valsartan	10 mg/12.5 mg/ 160 mg	022314	1	2009-10-22
EXFORGE HCT	Tablets	amlodipine besylate; hydrochlorothiazide; valsartan	5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mg	022314	1	2009-09-14

US Patents and Regulatory Information for EXFORGE HCT

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-001	Apr 30, 2009	AB	RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-004	Apr 30, 2009	AB	RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-002	Apr 30, 2009	AB	RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-003	Apr 30, 2009	AB	RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-005	Apr 30, 2009	AB	RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for EXFORGE HCT

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-002	Apr 30, 2009	⤷ Subscribe	⤷ Subscribe
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-005	Apr 30, 2009	⤷ Subscribe	⤷ Subscribe
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-004	Apr 30, 2009	⤷ Subscribe	⤷ Subscribe
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-001	Apr 30, 2009	⤷ Subscribe	⤷ Subscribe
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-003	Apr 30, 2009	⤷ Subscribe	⤷ Subscribe
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-003	Apr 30, 2009	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for EXFORGE HCT

When does loss-of-exclusivity occur for EXFORGE HCT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1627
Patent: FORMAS DE DOSIFICACION SOLIDAS DE VALSARTAN, AMLODIPINA, E HIDROCLOROTIAZIDA, Y METODO PARA ELABORARLAS
Estimated Expiration: ⤷ Subscribe

Australia

Patent: 07265138
Patent: Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same
Estimated Expiration: ⤷ Subscribe

Brazil

Patent: 0713785
Patent: formas de dosagem sólidas de valsartana, amlodipina e hidroclorotiazida e métodos de fabricação das mesmas
Estimated Expiration: ⤷ Subscribe

Canada

Patent: 54986
Patent: FORMES GALENIQUES SOLIDES DU VALSARTAN, DE L'AMLODIPINE ET DE L'HYDROCHLOROTHIAZIDE ET LEUR METHODE DE FABRICATION (SOLID DOSAGE FORMS OF VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE AND METHOD OF MAKING THE SAME)
Estimated Expiration: ⤷ Subscribe

Chile

Patent: 07001870
Patent: COMPOSICION FARMACEUTICA DE DOSIFICACION SOLIDA QUE COMPRENDE VALSARTAN, AMLODIPINA, HIDROCLOROTIAZIDA Y ADITIVOS FARMACEUTICAMENTE ACEPTABLES; PROCEDIMIENTO DE PREPARACION; Y USO PARA EL TRATAMIENTO DE HIPERTENSION, INSUFICIENCIA CARDIACA, INFARTO D
Estimated Expiration: ⤷ Subscribe

China

Patent: 1478956
Patent: Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same
Estimated Expiration: ⤷ Subscribe

Patent: 3169711
Patent: Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making same
Estimated Expiration: ⤷ Subscribe

Ecuador

Patent: 088987
Patent: FORMAS DE DOSIFICACIÓN SÓLIDAS DE VALSARTAN, AMLODIPINA, E HIDROCLOROTIAZIDA, Y MÉTODO PARA ELABORARLAS
Estimated Expiration: ⤷ Subscribe

European Patent Office

Patent: 37893
Patent: FORMES GALÉNIQUES SOLIDES DU VALSARTAN, DE L'AMLODIPINE ET DE L'HYDROCHLOROTHIAZIDE ET LEUR MÉTHODE DE FABRICATION (SOLID DOSAGE FORMS OF VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE AND METHOD OF MAKING THE SAME)
Estimated Expiration: ⤷ Subscribe

Hong Kong

Patent: 33818
Patent: SOLID DOSAGE FORMS OF VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE AND METHOD OF MAKING THE SAME
Estimated Expiration: ⤷ Subscribe

Japan

Patent: 09542709
Estimated Expiration: ⤷ Subscribe

Mexico

Patent: 08016532
Patent: FORMAS DE DOSIFICACION SOLIDAS DE VALSARTAN, AMLODIPINA, E HIDROCLOROTIAZIDA, Y METODO PARA ELABORARLAS. (SOLID DOSAGE FORMS OF VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE AND METHOD OF MAKING THE SAME.)
Estimated Expiration: ⤷ Subscribe

Morocco

Patent: 529
Patent: FORMES GALENIQUES SOLIDES DU VALSARTAN, DE L'AMLODIPINE ET DE L'HYDROCHLOROTHIAZIDE ET LEUR METHODE DE FABRICATION
Estimated Expiration: ⤷ Subscribe

New Zealand

Patent: 3295
Patent: Bilayer tablets containing a combination of valsartan, amlodipine and a diuretic and method of making the same
Estimated Expiration: ⤷ Subscribe

Norway

Patent: 090314
Estimated Expiration: ⤷ Subscribe

Peru

Patent: 080991
Patent: FORMAS DE DOSIFICACION SOLIDAS DE VALSARTAN, AMLODIPINA E HIDROCLOROTIAZIDA Y METODO PARA ELABORARLAS
Estimated Expiration: ⤷ Subscribe

Patent: 120542
Patent: FORMAS DE DOSIFICACION SOLIDAS DE VALSARTAN, AMLODIPINA E HIDROCLOROTIAZIDA Y METODO PARA ELABORARLAS
Estimated Expiration: ⤷ Subscribe

Russian Federation

Patent: 49786
Patent: ТВЕРДЫЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ ВАЛСАРТАНА, АМЛОДИПИНА И ГИДРОХЛОРТИАЗИДА И СПОСОБ ИХ ПОЛУЧЕНИЯ (SOLID DOSAGE FORMS OF VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE AND METHOD FOR MAKING THEM)
Estimated Expiration: ⤷ Subscribe

Patent: 09102273
Patent: ТВЕРДЫЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ ВАЛСАРТАНА, АМЛОДИПИНА И ГИДРОХЛОРТИАЗИДА И СПОСОБ ИХ ПОЛУЧЕНИЯ
Estimated Expiration: ⤷ Subscribe

South Africa

Patent: 0810053
Patent: Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same
Estimated Expiration: ⤷ Subscribe

South Korea

Patent: 090021191
Patent: SOLID DOSAGE FORMS OF VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE AND METHOD OF MAKING THE SAME
Estimated Expiration: ⤷ Subscribe

Taiwan

Patent: 0808379
Patent: Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same
Estimated Expiration: ⤷ Subscribe

Tunisia

Patent: 08538
Patent: SOLID DOSAGE FORMS OF VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE AND METHOD OF MAKING THE SAME
Estimated Expiration: ⤷ Subscribe

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EXFORGE HCT around the world.

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1019858		⤷ Subscribe
Hungary	220073	Antihipertenzív hatású aril-alkil-aminok acil-származékai és ezeket tartalmazó gyógyszerkészítmények (ACYL DERIVATIVES OF ARYL-ALKYL-AMINS WITH ANTIHYPERTENSIVE ACTIVITY AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEM)	⤷ Subscribe
China	1475207		⤷ Subscribe
Russian Federation	2324482	КОМБИНАЦИЯ ОРГАНИЧЕСКИХ СОЕДИНЕНИЙ (COMBINATION OF ORGANIC COMPOUNDS)	⤷ Subscribe
Austria	276750		⤷ Subscribe
Chile	2007001870	COMPOSICION FARMACEUTICA DE DOSIFICACION SOLIDA QUE COMPRENDE VALSARTAN, AMLODIPINA, HIDROCLOROTIAZIDA Y ADITIVOS FARMACEUTICAMENTE ACEPTABLES; PROCEDIMIENTO DE PREPARACION; Y USO PARA EL TRATAMIENTO DE HIPERTENSION, INSUFICIENCIA CARDIACA, INFARTO D	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for EXFORGE HCT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0678503	C300499	Netherlands	⤷ Subscribe	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
0443983	91676	Luxembourg	⤷ Subscribe	91676, EXPIRES: 20160212
0443983	C00443983/03	Switzerland	⤷ Subscribe	PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0443983	97C0050	France	⤷ Subscribe	PRODUCT NAME: VALSARTAN; REGISTRATION NO/DATE IN FRANCE: NL 22077 DU 19970321; REGISTRATION NO/DATE AT EEC: 369830000 DU 19960513
0503785	C300486	Netherlands	⤷ Subscribe	PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
0443983	2007C/043	Belgium	⤷ Subscribe	PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

EXFORGE HCT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EXFORGE HCT

Introduction

EXFORGE HCT, a medication combining amlodipine, valsartan, and hydrochlorothiazide, is used to treat essential hypertension in adults. This article delves into the market dynamics and financial trajectory of EXFORGE HCT, highlighting its performance, market impact, and the broader financial context of its manufacturer, Novartis.

Market Indications and Efficacy

EXFORGE HCT is indicated for the treatment of hypertension in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan, and hydrochlorothiazide. The medication is available in various strengths and has been shown to be more effective in lowering blood pressure compared to dual combinations of its active substances[4].

Market Launch and Approval

EXFORGE HCT received marketing authorization from the European Commission on October 16, 2009. The approval was based on clinical trials that demonstrated its efficacy and safety profile. The European Medicines Agency (EMA) noted that the highest strength of EXFORGE HCT was more effective than dual combinations of its active substances in treating hypertension[4].

Financial Performance

Quarterly and Annual Sales

EXFORGE HCT has been a significant contributor to Novartis's financial performance. In the second quarter of 2010, EXFORGE HCT sales increased by 37% in constant currencies, contributing to the overall strong financial performance of Novartis. The drug was part of a portfolio of recently launched products that generated $1.6 billion in net sales during that period, representing 21% of Novartis's net sales[5].

Revenue Growth

The success of EXFORGE HCT has been part of Novartis's broader strategy to drive revenue growth through innovative products. In 2010, Novartis reported an 8% increase in net sales, driven by volume growth and the performance of recently launched products, including EXFORGE HCT. This trend continued, with EXFORGE HCT and other new products contributing significantly to Novartis's revenue growth over subsequent years[5].

Market Impact

Competitive Landscape

EXFORGE HCT operates in a competitive hypertension treatment market. However, its unique combination of three active substances in a single tablet has been a key differentiator. The EMA noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed EXFORGE HCT, which combines these substances in a single tablet[4].

Patient Compliance

The single-tablet formulation of EXFORGE HCT has improved patient compliance. Studies have shown that patients are more likely to adhere to their treatment regimen when medications are combined into a single tablet, which can lead to better blood pressure control and overall health outcomes.

Financial Trajectory of Novartis

Overall Financial Performance

Novartis has consistently delivered strong financial performance, with significant contributions from its pharmaceutical division. In the third quarter of 2011, Novartis reported a 12% increase in sales and a 14% increase in core operating income, driven by the success of its recently launched products, including EXFORGE HCT[2].

Core Operating Income

The core operating income of Novartis's pharmaceutical division has seen steady growth, partly due to the commercial success of EXFORGE HCT and other new products. In 2010, core operating income rose by 35% in constant currencies, with the core operating income margin improving by 3.9 percentage points to 29.9% of net sales[5].

R&D and Product Pipeline

Novartis's continued investment in research and development (R&D) has been crucial for the success of EXFORGE HCT and other products. The company has a robust pipeline, and positive Phase III results for various products have contributed to its financial growth. The discovery and development of new drugs, which typically take 10 to 15 years, are key to Novartis's long-term financial ambitions[3].

Challenges and Risks

Competitive Pressures

The commercial success of EXFORGE HCT and other Novartis products can be impacted by competitive pressures, including new or existing competitive products, changes in prescribing habits, and pricing pressures. These factors can affect the revenue and margins of key products[3].

Regulatory and Market Risks

Regulatory proceedings, changes in labeling, loss of intellectual property protection, and global pandemics are among the risks that could impact the financial trajectory of EXFORGE HCT and Novartis's overall business. The company must navigate these challenges to maintain and grow its market share[3].

Key Takeaways

Market Efficacy: EXFORGE HCT has demonstrated superior efficacy in lowering blood pressure compared to dual combinations of its active substances.
Financial Contribution: The drug has been a significant contributor to Novartis's revenue growth, particularly in the hypertension treatment market.
Patient Compliance: The single-tablet formulation of EXFORGE HCT has improved patient compliance, leading to better health outcomes.
Competitive Landscape: EXFORGE HCT operates in a competitive market but stands out due to its unique combination of active substances.
Financial Trajectory: Novartis's financial performance has been strong, driven by the success of EXFORGE HCT and other innovative products.

FAQs

What is EXFORGE HCT used for?

EXFORGE HCT is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan, and hydrochlorothiazide.

When did EXFORGE HCT receive marketing authorization?

EXFORGE HCT received marketing authorization from the European Commission on October 16, 2009.

How has EXFORGE HCT contributed to Novartis's financial performance?

EXFORGE HCT has been a significant contributor to Novartis's revenue growth, with sales increasing by 37% in constant currencies in the second quarter of 2010.

What are the key benefits of EXFORGE HCT?

The key benefits include superior efficacy in lowering blood pressure, improved patient compliance due to its single-tablet formulation, and a favorable safety profile.

What are the potential risks and challenges for EXFORGE HCT?

Potential risks include competitive pressures, regulatory proceedings, changes in prescribing habits, and global pandemics, which can impact the commercial success and financial trajectory of the drug.

Sources

Novartis - EXFORGE HCT [PDF]
FierceBiotech - Novartis achieves strong third quarter financial performance and pipeline progress
AnnualReports.co.uk - Novartis Annual Report 2022 [PDF]
European Medicines Agency - Exforge HCT
FiercePharma - Novartis delivers strong financial performance in second quarter

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