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Last Updated: March 28, 2024

~ Buy the EXFORGE HCT (amlodipine besylate; hydrochlorothiazide; valsartan) Drug Profile, 2024 PDF Report in the Report Store ~

EXFORGE HCT Drug Patent Profile


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When do Exforge Hct patents expire, and when can generic versions of Exforge Hct launch?

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. Three suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

Drug patent expirations by year for EXFORGE HCT
Drug Prices for EXFORGE HCT

See drug prices for EXFORGE HCT

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

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-004 Apr 30, 2009 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-002 Apr 30, 2009 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-003 Apr 30, 2009 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-005 Apr 30, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

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
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 07265138
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0713785
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 54986
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 07001870
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1478956
Estimated Expiration: ⤷  Try a Trial

Patent: 3169711
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 088987
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 37893
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 33818
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 09542709
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 08016532
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 529
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 3295
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 090314
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 080991
Estimated Expiration: ⤷  Try a Trial

Patent: 120542
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 49786
Estimated Expiration: ⤷  Try a Trial

Patent: 09102273
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0810053
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 090021191
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 0808379
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 08538
Estimated Expiration: ⤷  Try a Trial

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.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2008002905 ⤷  Try a Trial
Taiwan I358291 ⤷  Try a Trial
Russian Federation 2009102273 ТВЕРДЫЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ ВАЛСАРТАНА, АМЛОДИПИНА И ГИДРОХЛОРТИАЗИДА И СПОСОБ ИХ ПОЛУЧЕНИЯ ⤷  Try a Trial
South Korea 20050000546 ⤷  Try a Trial
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 ⤷  Try a Trial
Israel 164925 תכשירים רוקחיים וערכות המכילים שילובים של ואלסרטן, אמלודיפין והידרוכלורותיאזיד (Pharmaceutical compositions and kits comprising combinations of valsartan, amlodipine and hydrochlorothiazide) ⤷  Try a Trial
Hungary T61271 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EXFORGE HCT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1507558 12C0033 France ⤷  Try a Trial PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705
1915993 C300625 Netherlands ⤷  Try a Trial 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 C300499 Netherlands ⤷  Try a Trial 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 C970001 Netherlands ⤷  Try a Trial PRODUCT NAME: VALSARTANUM, DESGEWENST IN DE VORM VAN EEN ZOUT OF IN DE VORM V AN EEN ESTER MET EEN HYDROXYVERBINDING MET DE FORMULE R-OH, WAA RIN R EEN LAAGALKYL-, FENYLLAAGALKYL-,LAAGALKENYL-,LAAGALKYNYL- ,LAAGALKOXY-LAAGALKYL-,LAAGALKOXY-LAAGALKENYL-OF LAAGALKOXY-LAA; NAT. REGISTRATION NO/DATE: RVG 20667, RVG 20668 19961104; FIRST REGISTRATION: 36983.00.00, 36983.01.00 19960513
1915993 92315 Luxembourg ⤷  Try a Trial PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
0443983 C300445 Netherlands ⤷  Try a Trial PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
0443983 C00443983/02 Switzerland ⤷  Try a Trial PRODUCT NAME: VALSARTAN UND AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57771 22.12.2006
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.