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Generated: August 14, 2018

DrugPatentWatch Database Preview

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 sixty-two patent family members in thirty-two 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
Teva Pharms AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 200435-004 Sep 25, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 206180-002 Dec 19, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lupin Ltd AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 200797-002 Jun 3, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-003 Apr 30, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Aurobindo Pharma Ltd AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 206180-004 Dec 19, 2017 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 201593-003 Jun 3, 2015 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

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International Patents for amlodipine besylate; hydrochlorothiazide; valsartan

Country Document Number Estimated Expiration
Israel 195797 ➤ Sign Up
Slovenia 1507529 ➤ Sign Up
Israel 164925 ➤ Sign Up
Canada 2654986 ➤ Sign Up
World Intellectual Property Organization (WIPO) 2008002905 ➤ Sign Up
Austria 429223 ➤ Sign Up
Mexico 2008016532 ➤ 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
0443983/03 Switzerland ➤ Sign Up PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
2011 00026 Denmark ➤ Sign Up 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
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
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
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
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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
US Department of Justice
Colorcon
Healthtrust
Queensland Health
Fuji
Federal Trade Commission
Chubb
Cerilliant

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