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Last Updated: March 19, 2024

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EXFORGE HCT Drug Patent Profile


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Drug patent expirations by year for EXFORGE HCT
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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
Austria 371449 ⤷  Try a Trial
European Patent Office 1767206 Formes orales solides comprenant du valsartan et de l'hydrochlorothiazide (Solid oral dosage forms comprising valsartan and hydrochlorothiazide) ⤷  Try a Trial
Australia 2007265138 Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same ⤷  Try a Trial
Japan 2000506540 ⤷  Try a Trial
Morocco 30529 FORMES GALENIQUES SOLIDES DU VALSARTAN, DE L'AMLODIPINE ET DE L'HYDROCHLOROTHIAZIDE ET LEUR METHODE DE FABRICATION ⤷  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
0443983 C00443983/03 Switzerland ⤷  Try a Trial PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0443983 C980036 Netherlands ⤷  Try a Trial 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 ⤷  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 SPC/GB97/009 United Kingdom ⤷  Try a Trial 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 ⤷  Try a Trial PRODUCT NAME: VALSARTAN; NAT. REGISTRATION NO/DATE: 206 IS 239 F 4 19970520; FIRST REGISTRATION: DE 36983.00.00 19960513
>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.