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Amlodipine besylate; hydrochlorothiazide; valsartan - Generic Drug Details

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Amlodipine besylate; hydrochlorothiazide; valsartan is the generic ingredient in two branded drugs marketed by Novartis, Teva Pharms, Par Pharm, Torrent Pharms Ltd, and Lupin Ltd, and is included in five NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are forty-nine drug master file entries for amlodipine besylate; hydrochlorothiazide; valsartan. Eight suppliers are listed for this compound.

Summary for Generic Name: amlodipine besylate; hydrochlorothiazide; valsartan

Tradenames:2
Patents:3
Applicants:5
NDAs:5
Drug Master File Entries: see list49
Suppliers / Packagers: see list8
Clinical Trials: see list244
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:amlodipine besylate; hydrochlorothiazide; valsartan at DailyMed

Pharmacology for Ingredient: amlodipine besylate; hydrochlorothiazide; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-004Apr 30, 2009RXYesNo8,475,839*PED► subscribeY► subscribe
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-003Apr 30, 2009RXYesNo8,475,839*PED► subscribeY► subscribe
Par Pharm
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL201087-004Jun 1, 2015RXNoNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: amlodipine besylate; hydrochlorothiazide; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-001Apr 30, 20095,399,578*PED► subscribe
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-002Apr 30, 20095,399,578*PED► subscribe
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-005Apr 30, 20095,399,578*PED► subscribe
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Non-Orange Book Patents for Generic Ingredient: amlodipine besylate; hydrochlorothiazide; valsartan

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
6,858,228 Solid oral dosage forms of valsartan► subscribe
6,485,745 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 Ingredient: amlodipine besylate; hydrochlorothiazide; valsartan

Country Document Number Estimated Expiration
South Korea20090099020► subscribe
Canada2673462► subscribe
Brazil9709956► 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: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0048France► subscribePRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
00375Netherlands► subscribePRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
0625Netherlands► subscribePRODUCT 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
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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 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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