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Harvard Business School
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Generated: June 28, 2017

DrugPatentWatch Database Preview

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, Ajanta Pharma Ltd, Torrent Pharms Ltd, Jubilant Generics, Teva Pharms Usa, and Macleods Pharms Ltd, and is included in seven NDAs. There are two patents 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 forty-nine drug master file entries for amlodipine besylate; olmesartan medoxomil. Nine 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:2
Applicants:7
NDAs:7
Drug Master File Entries: see list49
Suppliers / Packagers: see list9
Clinical Trials: see list524
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
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL091154-003Oct 26, 2016ABRXNoNo► Subscribe► Subscribe
Macleods Pharms Ltd
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL206884-001Oct 26, 2016ABRXNoNo► Subscribe► Subscribe
Jubilant Generics
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL207450-003May 15, 2017ABRXNoNo► Subscribe► Subscribe
Aurobindo Pharma Ltd
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL206906-004May 15, 2017ABRXNoNo► Subscribe► Subscribe
Jubilant Generics
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL207450-001May 15, 2017ABRXNoNo► Subscribe► Subscribe
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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;ORAL022100-004Sep 26, 20075,616,599*PED► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-001Sep 26, 20075,616,599*PED► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-003Sep 26, 20075,616,599*PED► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-002Sep 26, 20075,616,599*PED► 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
Israel114996► Subscribe
Czech Republic287764► Subscribe
Norway2003009► Subscribe
HungaryT64329► Subscribe
JapanH0578328► 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
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
C0048France► SubscribePRODUCT 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
0503785/04Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
0133Netherlands► Subscribe300133, 20120221, EXPIRES: 20170220
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Moodys
AstraZeneca
Cerilliant
Merck
Cipla
Novartis
Queensland Health
Daiichi Sankyo
US Department of Justice
Dow

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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