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Last Updated: May 26, 2022

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. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-two patent family members in thirty-two countries.

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.

DrugPatentWatch® Generic Entry Outlook for Exforge Hct

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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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

EXFORGE HCT is protected by one US patents.

Patents protecting EXFORGE HCT

Pharmaceutical composition containing anti-hypertensive agents
Patent Number: See Plans and Pricing
Patent Expiration: 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
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-001 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 022314-004 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 022314-004 Apr 30, 2009 AB RX Yes No 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 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: See Plans and Pricing

Australia

Patent: 07265138
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0713785
Estimated Expiration: See Plans and Pricing

Canada

Patent: 54986
Estimated Expiration: See Plans and Pricing

Chile

Patent: 07001870
Estimated Expiration: See Plans and Pricing

China

Patent: 1478956
Estimated Expiration: See Plans and Pricing

Patent: 3169711
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 088987
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 37893
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 33818
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5797
Estimated Expiration: See Plans and Pricing

Japan

Patent: 09542709
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 08016532
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 529
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3295
Estimated Expiration: See Plans and Pricing

Norway

Patent: 090314
Estimated Expiration: See Plans and Pricing

Peru

Patent: 080991
Estimated Expiration: See Plans and Pricing

Patent: 120542
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 49786
Estimated Expiration: See Plans and Pricing

Patent: 09102273
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0810053
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 090021191
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 0808379
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 08538
Estimated Expiration: See Plans and Pricing

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
Ireland 71155 Acyl compounds See Plans and Pricing
Finland 910747 See Plans and Pricing
Hungary T61271 See Plans and Pricing
Canada 2036427 COMPOSES ACYLES (ACYL COMPOUNDS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EXFORGE HCT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1915993 300625 Netherlands See Plans and Pricing 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
0503785 CA 2011 00026 Denmark See Plans and Pricing 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
1507558 12C0033 France See Plans and Pricing 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
0443983 CA 2010 00014 Denmark See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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.