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Amlodipine besylate; valsartan - Generic Drug Details

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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, 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.

This ingredient has eighty patent family members in thirty-three countries.

There are forty-eight drug master file entries for amlodipine besylate; valsartan. Fourteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: amlodipine besylate; valsartan

Tradenames:2
Patents:2
Applicants:9
NDAs:10
Drug Master File Entries: see list48
Suppliers / Packaging: see list14
Formulation / Manufacturing:see details

Pharmacology for Ingredient: amlodipine besylate; valsartan

Tentative approvals for AMLODIPINE BESYLATE; VALSARTAN

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORALEQ 5MG BASE;320MG
<disabled><disabled>TABLET; ORALEQ 10MG BASE;320MG

Clinical Trials for: amlodipine besylate; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novel Labs Inc
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL202829-004Mar 30, 2015RXNo<disabled><disabled>
Par Pharm Inc
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL090011-002Mar 28, 2013RXNo<disabled><disabled>
Torrent Pharms Ltd
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL202377-002Mar 30, 2015RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: amlodipine besylate; valsartan

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-002Jun 20, 20075,399,578*PED<disabled>
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-005Jun 20, 20075,399,578*PED<disabled>
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-003Jun 20, 20075,399,578*PED<disabled>
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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
6,858,228 Solid oral dosage forms of valsartan<disabled in preview>
6,204,281 Method of treatment and pharmaceutical composition<disabled in preview>
6,485,745 Solid oral dosage forms of valsartan<disabled in preview>
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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
United Kingdom9613470<disabled in preview>
China1475207<disabled in preview>
Japan2003231634<disabled in preview>
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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
12/018Ireland<disabled>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
0443983/03Switzerland<disabled>PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
2011 00026Denmark<disabled>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
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