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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
UBS
Boehringer Ingelheim
AstraZeneca
Cerilliant
Novartis
Dow
Argus Health
Julphar
Federal Trade Commission

Generated: August 21, 2017

DrugPatentWatch Database Preview

EXFORGE HCT Drug Profile

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What is the patent landscape for Exforge Hct, and what generic Exforge Hct alternatives are available?

Exforge Hct is a drug marketed by Novartis and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and fourteen patent family members in thirty-six countries.

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

Summary for Tradename: EXFORGE HCT

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Clinical Trials: see list249
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:EXFORGE HCT at DailyMed
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;ORAL022314-001Apr 30, 2009ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-003Apr 30, 2009ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-002Apr 30, 2009ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-004Apr 30, 2009ABRXYesNo► Subscribe► SubscribeY► Subscribe
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-003Apr 30, 2009ABRXYesNo► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: EXFORGE HCT

Paragraph IV activity for: EXFORGE HCT

Drugname Dosage Strength RLD Submissiondate
amlodipine, hydrochlorothiazide and valsartanTablets5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mExforge HCT9/14/2009
amlodipine, hydrochlorothiazide and valsartanTablets10 mg/12.5 mg/160 mgExforge HCT10/22/2009

Non-Orange Book Patents for Tradename: EXFORGE HCT

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,485,745 Solid oral dosage forms of valsartan► Subscribe
6,858,228 Solid oral dosage forms of valsartan► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: EXFORGE HCT

Country Document Number Estimated Expiration
Denmark1410797► Subscribe
Poland188271► Subscribe
Japan2012051948► Subscribe
Malaysia146868► Subscribe
South Korea20110063587► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: EXFORGE HCT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00499Netherlands► SubscribePRODUCT 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
C/GB11/010United Kingdom► SubscribePRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
00486Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
00445Netherlands► SubscribePRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
2011 00026Denmark► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Merck
McKesson
Covington
Accenture
Moodys
Citi
Cantor Fitzgerald
Federal Trade Commission
US Department of Justice

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 verifification 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.

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