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Amlodipine besylate; olmesartan medoxomil - Generic Drug Details

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

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

This ingredient has ninety-eight patent family members in twenty-seven countries.

There are forty-nine drug master file entries for amlodipine besylate; olmesartan medoxomil. Seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: amlodipine besylate; olmesartan medoxomil

Tradenames:2
Patents:2
Applicants:5
NDAs:5
Drug Master File Entries: see list49
Suppliers / Packagers: see list7
Clinical Trials: see list175
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. Form Dosage
► Subscribe► SubscribeTABLET; ORAL5MG/20MG
► Subscribe► SubscribeTABLET; ORAL5MG/40MG
► Subscribe► SubscribeTABLET; ORAL10MG/20MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Macleods Pharms Ltd
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL206884-001Oct 26, 2016RXNoNo► Subscribe► Subscribe
Ajanta Pharma Ltd
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL207216-004Oct 28, 2016RXNoNo► Subscribe► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-001Sep 26, 2007RXYesNo5,616,599*PED► Subscribe ► Subscribe
Teva Pharms Usa
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL091154-001Oct 26, 2016RXNoNo► Subscribe► Subscribe
Torrent Pharms Llc
AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL202933-001Nov 25, 2016RXNoNo► 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, 20075,616,599*PED► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-004Sep 26, 20075,616,599*PED► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-002Sep 26, 20075,616,599*PED► Subscribe
Daiichi Sankyo
AZOR
amlodipine besylate; olmesartan medoxomil
TABLET;ORAL022100-003Sep 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
China1188645► Subscribe
Norway2009019► Subscribe
Netherlands300227► Subscribe
Norway304516► Subscribe
Luxembourg91571► 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
00133Netherlands► SubscribePRODUCT NAME: OLMESARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN DE CARBOXYGROEP GEKOZEN UIT DE VOLGENDE : EEN ALKYLGROEP 1-4 KOOLSTOFATOMEN, EEN BENZYLGROEP, EEN ALKANOYLOXYALKYLGROEP WAARIN HET ALKANOYLDEEL 1-5; NATL. REGISTRATION NO/DATE: RVG 28785-RVG 28787 20030527; FIRST REGISTRATION: DE 502.02.00.00,502.02.01.00, 502.02.02.00 20020813
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
0133Netherlands► Subscribe300133, 20120221, EXPIRES: 20170220
00445Netherlands► SubscribePRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
00528Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
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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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