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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, 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.

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

There are forty-nine drug master file entries for amlodipine besylate; valsartan. Fifteen 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:10
NDAs:10
Drug Master File Entries: see list49
Suppliers / Packaging: see list15
Formulation / Manufacturing:see details
Drug Prices:see low prices

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
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL091235-002Mar 30, 2015RXNo► subscribe► subscribe
Teva Pharms Usa
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL091235-001Mar 30, 2015RXNo► subscribe► subscribe
Mylan Pharms Inc
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL090483-003Mar 30, 2015RXNo► subscribe► subscribe
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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► subscribe
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-004Jun 20, 20075,399,578*PED► subscribe
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-005Jun 20, 20075,399,578*PED► 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
6,858,228 Solid oral dosage forms of valsartan► subscribe
6,204,281 Method of treatment and pharmaceutical composition► 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
Colombia4870755► subscribe
China1951372► subscribe
Japan4969338► 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
00478Netherlands► subscribePRODUCT 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
07C/043Belgium► subscribePRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
13/058Ireland► subscribePRODUCT NAME: COMBINATION COMPRISING ALISKIREN, OR A PHARMACEUTICAL ACCEPTABLE SALT THEREOF, AND AMLODIPINE, OR A PHARMACEUTICAL ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/11/686/001-EU/1/11/686/056 20110414
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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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