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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Colorcon
Cipla
US Department of Justice
McKesson
Novartis
Medtronic
Julphar
Healthtrust
Argus Health

Generated: August 17, 2017

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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 Par Pharm Inc, Aurobindo Pharma Ltd, Alembic Pharms Ltd, Novel Labs Inc, Teva Pharms Usa, Invagen Pharms, Lupin, Torrent Pharms Ltd, Mylan Pharms Inc, 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 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 Generic Name: amlodipine besylate; valsartan

Tradenames:2
Patents:2
Applicants:10
NDAs:10
Drug Master File Entries: see list50
Suppliers / Packagers: see list14
Clinical Trials: see list631
Drug Prices:see low prices
DailyMed Link:amlodipine besylate; valsartan at DailyMed

Pharmacology for Ingredient: amlodipine besylate; valsartan

Expired Orange Book Patents for Generic Ingredient: amlodipine besylate; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-002Jun 20, 2007► Subscribe► Subscribe
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-005Jun 20, 2007► Subscribe► Subscribe
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-004Jun 20, 2007► Subscribe► Subscribe
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-003Jun 20, 2007► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
6,858,228 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; valsartan

Country Document Number Estimated Expiration
Japan2003231634► Subscribe
Russian Federation2009115778► Subscribe
South Korea101161283► Subscribe
Australia3340297► Subscribe
Canada2259148► 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; VALSARTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
00445Netherlands► SubscribePRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
07C/043Belgium► SubscribePRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
00528Netherlands► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Merck
AstraZeneca
Fish and Richardson
Deloitte
Fuji
Chubb
Queensland Health
Healthtrust
Covington
Teva

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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