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Amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil?

Amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil is the generic ingredient in two branded drugs marketed by Par Pharm Inc, Daiichi Sankyo, Torrent Pharms Ltd, and Teva Pharms Usa, and is included in four NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are forty-nine drug master file entries for amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil. Five suppliers are listed for this compound.

Summary for Generic Name: amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil

Tradenames:2
Patents:2
Applicants:4
NDAs:4
Drug Master File Entries: see list49
Suppliers / Packagers: see list5
Clinical Trials: see list224
Drug Prices:see low prices
DailyMed Link:amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil at DailyMed

Pharmacology for Ingredient: amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL202491-005Nov 3, 2016RXNoNo► Subscribe► Subscribe
Daiichi Sankyo
TRIBENZOR
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL200175-001Jul 23, 2010RXYesNo5,616,599*PED► Subscribe ► Subscribe
Par Pharm Inc
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL206137-003Oct 26, 2016RXNoNo► Subscribe► Subscribe
Par Pharm Inc
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL206137-002Oct 26, 2016RXNoNo► Subscribe► Subscribe
Par Pharm Inc
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL206137-005Oct 26, 2016RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo
TRIBENZOR
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL200175-001Jul 23, 20105,616,599*PED► Subscribe
Daiichi Sankyo
TRIBENZOR
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL200175-002Jul 23, 20105,616,599*PED► Subscribe
Daiichi Sankyo
TRIBENZOR
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL200175-005Jul 23, 20105,616,599*PED► Subscribe
Daiichi Sankyo
TRIBENZOR
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL200175-004Jul 23, 20105,616,599*PED► Subscribe
Daiichi Sankyo
TRIBENZOR
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL200175-003Jul 23, 20105,616,599*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: amlodipine besylate; hydrochlorothiazide; 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; hydrochlorothiazide; olmesartan medoxomil

Country Document Number Estimated Expiration
Netherlands300133► Subscribe
Germany122005000051► Subscribe
Israel114996► Subscribe
Czech Republic9200516► Subscribe
Luxembourg91847► 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; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2009Austria► SubscribePRODUCT NAME: KOMBINATION VON OLMESARTAN MEDOXOMIL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, MIT AMLODIPINBESILAT; NAT. REGISTRATION NO/DATE: 1-27894, 1-27895, 1-27896 20081217; FIRST REGISTRATION: NL 100989, 100990, 100991 20080819
00499Netherlands► SubscribePRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
12/018Ireland► SubscribePRODUCT 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
2011 00026Denmark► SubscribePRODUCT 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
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
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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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