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Generated: December 18, 2017

DrugPatentWatch Database Preview

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - Generic Drug Details

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What are the generic sources for amlodipine besylate; hydrochlorothiazide; valsartan and what is the scope of amlodipine besylate; hydrochlorothiazide; valsartan freedom to operate?

Amlodipine besylate; hydrochlorothiazide; valsartan
is the generic ingredient in two branded drugs marketed by Lupin Ltd, Par Pharm, Teva Pharms, Torrent Pharms Ltd, and Novartis, 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.

Amlodipine besylate; hydrochlorothiazide; valsartan has one hundred and twenty-four patent family members in thirty-six countries and sixteen supplementary protection certificates in eight countries.

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

Summary for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Pharmacology for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Torrent Pharms LtdAMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL201593-003Jun 3, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Torrent Pharms LtdAMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL201593-005Jun 3, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
NovartisEXFORGE HCTamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL022314-004Apr 30, 2009ABRXYesNo► Subscribe► SubscribeY► Subscribe
Par PharmAMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL201087-005Jun 1, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
NovartisEXFORGE HCTamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL022314-005Apr 30, 2009ABRXYesYes► Subscribe► SubscribeY► Subscribe
Lupin LtdAMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL200797-003Jun 3, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin LtdAMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL200797-004Jun 3, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva PharmsAMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL200435-004Sep 25, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Torrent Pharms LtdAMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL201593-001Jun 3, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
NovartisEXFORGE HCTamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL022314-002Apr 30, 2009ABRXYesNo► Subscribe► SubscribeY► 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
NovartisEXFORGE HCTamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL022314-004Apr 30, 2009► Subscribe► Subscribe
NovartisEXFORGE HCTamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL022314-001Apr 30, 2009► Subscribe► Subscribe
NovartisEXFORGE HCTamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL022314-003Apr 30, 2009► Subscribe► Subscribe
NovartisEXFORGE HCTamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL022314-002Apr 30, 2009► Subscribe► Subscribe
NovartisEXFORGE HCTamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL022314-005Apr 30, 2009► Subscribe► 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
6,485,745 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 Ingredient: amlodipine besylate; hydrochlorothiazide; valsartan

Country Document Number Estimated Expiration
Norway331739► Subscribe
Japan2005533023► Subscribe
Malaysia146868► Subscribe
South Korea20090099020► Subscribe
Taiwan473394► Subscribe
South Korea20110063587► Subscribe
Denmark0914119► Subscribe
Norway333011► Subscribe
Malaysia138838► Subscribe
Peru87498► 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
315Luxembourg► SubscribePRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
07C/043Belgium► SubscribePRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
00478Netherlands► SubscribePRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
C0033France► SubscribePRODUCT 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: 6167801 20110705
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
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
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
00625Netherlands► 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
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
0443983/03Switzerland► SubscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
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Serving leading biopharmaceutical companies globally:

UBS
Chubb
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US Army
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McKinsey
US Department of Justice
Mallinckrodt
Federal Trade Commission

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