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Chubb
Healthtrust
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Harvard Business School
Cantor Fitzgerald
Dow
UBS
Mallinckrodt
McKinsey
Covington

Generated: February 25, 2018

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Amlodipine besylate; hydrochlorothiazide; valsartan - Generic Drug Details

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What are the generic drug sources for amlodipine besylate; hydrochlorothiazide; valsartan and what is the scope of amlodipine besylate; hydrochlorothiazide; valsartan patent protection?

Amlodipine besylate; hydrochlorothiazide; valsartan
is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Lupin Ltd, Par Pharm, Teva Pharms, Torrent Pharms Ltd, and Novartis, and is included in six NDAs. There are two 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 thirty-seven patent family members in twenty-nine countries.

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

US Patents and Regulatory Information 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
Par Pharm AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 201087-001 Jun 1, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lupin Ltd AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 200797-003 Jun 3, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Torrent Pharms Ltd AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 201593-004 Jun 3, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Pharms AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 200435-005 Sep 25, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-004 Apr 30, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Torrent Pharms Ltd AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 201593-003 Jun 3, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-001 Apr 30, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-005 Apr 30, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-004 Apr 30, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Teva Pharms AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 200435-001 Sep 25, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for amlodipine besylate; hydrochlorothiazide; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-004 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-005 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-001 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-003 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-004 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-002 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-003 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-002 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-001 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-005 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for amlodipine besylate; hydrochlorothiazide; valsartan

Country Document Number Estimated Expiration
Mexico PA04011385 ➤ Sign Up
Norway 333011 ➤ Sign Up
Israel 164925 ➤ Sign Up
Denmark 1507529 ➤ Sign Up
Australia 2003240261 ➤ Sign Up
Canada 2486144 ➤ Sign Up
Japan 5132872 ➤ Sign Up
Taiwan 200406204 ➤ Sign Up
Austria 429223 ➤ Sign Up
Taiwan I358291 ➤ Sign Up
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for amlodipine besylate; hydrochlorothiazide; valsartan

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0048 France ➤ Sign Up PRODUCT 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
00375 Netherlands ➤ Sign Up PRODUCT 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
0625 Netherlands ➤ Sign Up 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
00499 Netherlands ➤ Sign Up PRODUCT 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
00528 Netherlands ➤ Sign Up PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
00486 Netherlands ➤ Sign Up PRODUCT 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
07C/043 Belgium ➤ Sign Up PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
00478 Netherlands ➤ Sign Up PRODUCT 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
00625 Netherlands ➤ Sign Up 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
0443983/03 Switzerland ➤ Sign Up PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Argus Health
Colorcon
Deloitte
Boehringer Ingelheim
US Army
Merck
McKinsey
Dow

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