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Serving leading biopharmaceutical companies globally:

McKesson
Fish and Richardson
Chubb
Chinese Patent Office
Medtronic
UBS
Citi
Fuji
AstraZeneca
Harvard Business School

Generated: October 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, Alkem Labs Ltd, Jubilant Generics, Teva Pharms Usa, Zydus Pharms Usa Inc, Alembic Pharms Ltd, and Macleods Pharms Ltd, and is included in eleven 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 one hundred and one patent family members in twenty-seven countries and thirty-two supplementary protection certificates in nine countries.

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

Summary for Generic Name: amlodipine besylate; olmesartan medoxomil

US Patents:1
Tradenames:2
Applicants:11
NDAs:11
Drug Master File Entries: see list50
Suppliers / Packagers: see list14
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
u► Subscribe5MG/20MGTABLET; ORAL
u► Subscribe10MG/40MGTABLET; ORAL
u► 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
Ajanta Pharma Ltd
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL207216-001Oct 28, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-003Sep 26, 2007ABRXYesNo► Subscribe► Subscribe ► Subscribe
Torrent Pharms Ltd
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL202933-003Nov 25, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Macleods Pharms Ltd
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL206884-002Oct 26, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Macleods Pharms Ltd
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL206884-001Oct 26, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-002Sep 26, 2007ABRXYesNo► Subscribe► Subscribe ► Subscribe
Alkem Labs Ltd
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL209042-004Aug 14, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Alkem Labs Ltd
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL209042-003Aug 14, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL206906-003May 15, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Jubilant Generics
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL207450-001May 15, 2017ABRXNoNo► Subscribe► 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;ORAL022100-001Sep 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;ORAL022100-004Sep 26, 2007► Subscribe► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-002Sep 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
Australia3988093► Subscribe
Iceland1756► Subscribe
Czech Republic287764► Subscribe
Austria200777► Subscribe
Denmark0503785► Subscribe
JapanH07121918► Subscribe
HungaryT64329► Subscribe
Hungary211934► Subscribe
Spain2155827► Subscribe
Norway2009019► 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
0503785/02Switzerland► SubscribeFORMER OWNER: SANKYO COMPANY LIMITED, JP
07C/043Belgium► SubscribePRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
0503785/04Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
0443983/03Switzerland► SubscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
315Luxembourg► SubscribePRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
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
C0037France► SubscribePRODUCT NAME: OLMESARTAN MEDOXOMIL; NAT. REGISTRATION NO/DATE: NL28292 20030806; FIRST REGISTRATION: DE - 50202.00 20020813
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
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
0133Netherlands► Subscribe300133, 20120221, EXPIRES: 20170220
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Accenture
Fuji
Baxter
Cerilliant
Johnson and Johnson
Chubb
Argus Health
Cipla
Chinese Patent Office

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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