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Last Updated: March 20, 2023

EXFORGE Drug Patent Profile


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

Exforge is a drug marketed by Novartis and is included in two NDAs. There are two patents protecting this drug and four Paragraph IV challenges.

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

DrugPatentWatch® Generic Entry Outlook for Exforge

There are four Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Paragraph IV (Patent) Challenges for EXFORGE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EXFORGE Tablets amlodipine besylate; valsartan 5 mg/320 mg 021990 1 2007-11-26
EXFORGE Tablets amlodipine besylate; valsartan 10 mg/320 mg 021990 1 2007-11-09
EXFORGE Tablets amlodipine besylate; valsartan 5 mg/160 mg 021990 1 2007-10-22
EXFORGE Tablets amlodipine besylate; valsartan 10 mg/160 mg 021990 1 2007-10-01

US Patents and Regulatory Information for EXFORGE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-002 Jun 20, 2007 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-002 Apr 30, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-005 Jun 20, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-004 Apr 30, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-002 Apr 30, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-005 Apr 30, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

International Patents for EXFORGE

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

Country Patent Number Title Estimated Expiration
Austria 371449 See Plans and Pricing
European Patent Office 1767206 Formes orales solides comprenant du valsartan et de l'hydrochlorothiazide (Solid oral dosage forms comprising valsartan and hydrochlorothiazide) See Plans and Pricing
Japan 2000506540 See Plans and Pricing
South Korea 101208430 See Plans and Pricing
Hong Kong 1019858 See Plans and Pricing
Mexico 24598 PROCEDIMIENTO PARA PREPARAR UN COMPUESTO DE ACILO, PRODUCTO OBTENIDO Y PREPARACION FARMACEUTICA QUE LO INCLUYE. See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EXFORGE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0443983 C00443983/03 Switzerland See Plans and Pricing PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0443983 C980036 Netherlands See Plans and Pricing PRODUCT NAME: VALSARTANUM, DESGEWENST IN DE VORM VAN EEN ZOUT OF IN DE VORM VAN EEN ESTER MET EEN HYDROXYVERBINDING MET DE FORMULE R-OH, WAARIN R EEN LAAGALKYL-, FENYLLAAGALKYL-, LAAGALKENYL-, LAAGAL- KYNYL-, LAAGALKOXY-LAAGALKYL-, LAAGALKOXY-LAAGALKENYL- OF -----; NAT. REGISTRATION NO/DATE: RVG 22365 19980525; FIRST REGISTRATION: 344 300-5344 301-1344 302-8344 303-4 1997250925
1915993 92315 Luxembourg See Plans and Pricing PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
0443983 SPC/GB97/009 United Kingdom See Plans and Pricing PRODUCT NAME: VALSARTAN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE 36983.00.00 19960513; DE 36983.01.00 19960513; UK 00001/0218 19961016; UK 00001/0219 19961016; UK 00001/0225 19961016
0443983 97C0039 Belgium See Plans and Pricing PRODUCT NAME: VALSARTAN; NAT. REGISTRATION NO/DATE: 206 IS 239 F 4 19970520; FIRST REGISTRATION: DE 36983.00.00 19960513
1507558 2012/018 Ireland See Plans and Pricing 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

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