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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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Queensland Health
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Generated: January 19, 2018

DrugPatentWatch Database Preview

Amlodipine besylate; valsartan - Generic Drug Details

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

Amlodipine besylate; valsartan
is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Aurobindo Pharma Ltd, Invagen Pharms, Lupin, Mylan Pharms Inc, Novel Labs Inc, Par Pharm Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Novartis, and is included in ten NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Amlodipine besylate; valsartan has eighty-seven patent family members in thirty-three countries.

There are fifty drug master file entries for amlodipine besylate; valsartan. Fourteen suppliers are listed for this compound.
Summary for amlodipine besylate; valsartan
International Patents:87
US Patents:2
Tradenames:2
Applicants:10
NDAs:10
Drug Master File Entries: 50
Suppliers / Packagers: 14
Clinical Trials: 639
Drug Prices:see low prices
DailyMed Link:amlodipine besylate; valsartan at DailyMed

US Patents and Regulatory Information for amlodipine besylate; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novel Labs Inc AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 202829-003 Mar 30, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Torrent Pharms Ltd AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 202377-003 Mar 30, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Pharm Inc AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 090011-003 Mar 28, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-003 Jun 20, 2007 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Lupin AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 090245-001 Mar 30, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Alembic Pharms Ltd AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 202713-004 Apr 3, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Alembic Pharms Ltd AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 202713-003 Apr 3, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Aurobindo Pharma Ltd AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 206512-002 Apr 22, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Pharms Usa AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 091235-004 Mar 30, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Pharms Usa AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 091235-002 Mar 30, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-004 Jun 20, 2007 ➤ Subscribe ➤ Subscribe
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-002 Jun 20, 2007 ➤ Subscribe ➤ Subscribe
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-005 Jun 20, 2007 ➤ Subscribe ➤ Subscribe
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-005 Jun 20, 2007 ➤ Subscribe ➤ Subscribe
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-002 Jun 20, 2007 ➤ Subscribe ➤ Subscribe
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-004 Jun 20, 2007 ➤ Subscribe ➤ Subscribe
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-003 Jun 20, 2007 ➤ Subscribe ➤ Subscribe
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-003 Jun 20, 2007 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for amlodipine besylate; 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
6,204,281 Method of treatment and pharmaceutical composition ➤ Subscribe
6,485,745 Solid oral dosage forms of valsartan ➤ Subscribe
6,858,228 Solid oral dosage forms of valsartan ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for amlodipine besylate; valsartan

Supplementary Protection Certificates for amlodipine besylate; valsartan

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00528 Netherlands ➤ Subscribe 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
00478 Netherlands ➤ Subscribe 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
0443983/03 Switzerland ➤ Subscribe PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
00486 Netherlands ➤ Subscribe 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
12/018 Ireland ➤ Subscribe PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
C/GB11/010 United Kingdom ➤ Subscribe PRODUCT 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
00375 Netherlands ➤ Subscribe 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 ➤ Subscribe 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
315 Luxembourg ➤ Subscribe PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
C0048 France ➤ Subscribe 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Novartis
Dow
UBS
Cerilliant
McKesson
Queensland Health
Colorcon
Daiichi Sankyo

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