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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Fish and Richardson
Covington
US Army
Fuji
Julphar
Citi
Moodys
Baxter
Colorcon

Generated: August 17, 2017

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Amlodipine besylate; olmesartan medoxomil - Generic Drug Details

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What are the generic drug sources for amlodipine besylate; olmesartan medoxomil and what is the scope of amlodipine besylate; olmesartan medoxomil freedom to operate?

Amlodipine besylate; olmesartan medoxomil
is the generic ingredient in two branded drugs marketed by Daiichi Sankyo, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Ajanta Pharma Ltd, Torrent Pharms Ltd, Jubilant Generics, Teva Pharms Usa, and Macleods Pharms Ltd, and is included in eight NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Amlodipine besylate; olmesartan medoxomil has ninety-eight patent family members in twenty-seven countries.

There are fifty drug master file entries for amlodipine besylate; olmesartan medoxomil. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: amlodipine besylate; olmesartan medoxomil

Tradenames:2
Patents:1
Applicants:8
NDAs:8
Drug Master File Entries: see list50
Suppliers / Packagers: see list10
Clinical Trials: see list527
Drug Prices:see low prices
DailyMed Link:amlodipine besylate; olmesartan medoxomil at DailyMed

Pharmacology for Ingredient: amlodipine besylate; olmesartan medoxomil

Tentative approvals for AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe5MG/20MGTABLET; ORAL
► Subscribe► Subscribe10MG/40MGTABLET; ORAL
► Subscribe► Subscribe10MG/20MGTABLET; ORAL

Expired Orange Book Patents for Generic Ingredient: amlodipine besylate; olmesartan medoxomil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-001Sep 26, 2007► Subscribe► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-003Sep 26, 2007► Subscribe► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-002Sep 26, 2007► Subscribe► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-004Sep 26, 2007► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: amlodipine besylate; olmesartan medoxomil

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
5,646,171 Angiotensin II antagonist 1-biphenylmethylimidazole compounds and their therapeutic use► 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; olmesartan medoxomil

Country Document Number Estimated Expiration
Portugal545912► Subscribe
Germany69231798► Subscribe
Luxembourg91330► Subscribe
Denmark0503785► Subscribe
Israel101034► 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; OLMESARTAN MEDOXOMIL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
056Luxembourg► Subscribe91056, EXPIRES: 20170221
0503785/04Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
C/GB03/024United Kingdom► SubscribePRODUCT NAME: OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHAMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE 50202.00.00 20020813; DE 50202.01.00 20020813; DE 50202.02.00 20020813; DE 50205.00.00 20020813; DE 50205.01.00 20020813; DE 50205.02.00 20020813; UK PL 08265/0015 20030522; UK PL 08265/0016 20030522; UK PL08265/0017 20030522
00375Netherlands► SubscribePRODUCT 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
C0033France► SubscribePRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: 6167801 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:

Julphar
McKinsey
US Army
Citi
Mallinckrodt
Farmers Insurance
Deloitte
Chubb
Chinese Patent Office
Johnson and Johnson

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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