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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:	14
Formulation / Manufacturing:	see details
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
Novartis Pharmaceuticals	Phase 4
Hanlim Pharm. Co., Ltd.	Phase 1
Dong-A Pharmaceutical 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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-004	Apr 30, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-002	Apr 30, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-003	Apr 30, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-005	Apr 30, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	022314-003	Apr 30, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-005	Apr 30, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-002	Apr 30, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-002	Apr 30, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-005	Apr 30, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-005	Apr 30, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-001	Apr 30, 2009	⤷ Sign Up	⤷ Sign Up
>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: ⤷ Sign Up

Australia

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

Brazil

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

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: ⤷ Sign Up

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: ⤷ Sign Up

China

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

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

Ecuador

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

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: ⤷ Sign Up

Hong Kong

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

Japan

Patent: 09542709
Estimated Expiration: ⤷ Sign Up

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: ⤷ Sign Up

Morocco

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

New Zealand

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

Norway

Patent: 090314
Estimated Expiration: ⤷ Sign Up

Peru

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

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

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: ⤷ Sign Up

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

South Africa

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

South Korea

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

Taiwan

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

Tunisia

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

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
South Korea	100618038		⤷ Sign Up
Australia	644844		⤷ Sign Up
Russian Federation	2294743	ТВЕРДЫЕ ОРАЛЬНЫЕ ДОЗИРУМЫЕ ФОРМЫ НА ОСНОВЕ ВАЛЬСАРТАНА (VALSARTAN-BASE SOLID ORAL DOSING FORMULATIONS)	⤷ Sign Up
Israel	164925	תכשירים רוקחיים וערכות המכילים שילובים של ואלסרטן, אמלודיפין והידרוכלורותיאזיד (Pharmaceutical compositions and kits comprising combinations of valsartan, amlodipine and hydrochlorothiazide)	⤷ Sign Up
South Korea	0171409		⤷ Sign Up
South Korea	20060079260		⤷ Sign Up
China	1951372		⤷ Sign Up
>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
0443983	C00443983/02	Switzerland	⤷ Sign Up	PRODUCT NAME: VALSARTAN UND AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57771 22.12.2006
0443983	97C0039	Belgium	⤷ Sign Up	PRODUCT NAME: VALSARTAN; NAT. REGISTRATION NO/DATE: 206 IS 239 F 4 19970520; FIRST REGISTRATION: DE 36983.00.00 19960513
0503785	CA 2011 00026	Denmark	⤷ Sign Up	PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
0443983	97C0050	France	⤷ Sign Up	PRODUCT NAME: VALSARTAN; REGISTRATION NO/DATE IN FRANCE: NL 22077 DU 19970321; REGISTRATION NO/DATE AT EEC: 369830000 DU 19960513
0443983	91676	Luxembourg	⤷ Sign Up	91676, EXPIRES: 20160212
0503785	C300375	Netherlands	⤷ Sign Up	PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
1507558	2012/018	Ireland	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description