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Serving 500+ biopharmaceutical companies globally:

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Generated: September 21, 2017

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Amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil - Generic Drug Details

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What are the generic sources for amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil and what is the scope of amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil patent protection?

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 is one patent 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 fifty 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:1
Applicants:4
NDAs:4
Drug Master File Entries: see list50
Suppliers / Packagers: see list5
Clinical Trials: see list740
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 TE 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;ORAL202491-001Nov 3, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Par Pharm Inc
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL206137-004Oct 26, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Torrent Pharms Ltd
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL203580-004Oct 26, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Torrent Pharms Ltd
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL203580-001Oct 26, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Daiichi Sankyo
TRIBENZOR
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL200175-004Jul 23, 2010ABRXYesNo► Subscribe► Subscribe ► Subscribe
Daiichi Sankyo
TRIBENZOR
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL200175-005Jul 23, 2010ABRXYesYes► Subscribe► Subscribe ► Subscribe
Teva Pharms Usa
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL202491-003Nov 3, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Par Pharm Inc
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL206137-002Oct 26, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL202491-005Nov 3, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Par Pharm Inc
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL206137-005Oct 26, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil

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
Norway931980► Subscribe
Hungary9301600► Subscribe
Luxembourg91571► Subscribe
Hungary223338► Subscribe
Germany122005000051► Subscribe
European Patent Office0573218► Subscribe
Austria200777► Subscribe
Russian Federation2128173► Subscribe
China1188645► Subscribe
Portugal545912► 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
0503785/03Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
00478Netherlands► SubscribePRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
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
571Luxembourg► Subscribe91571, EXPIRES: 20170221
330Luxembourg► SubscribeCERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS)
2011Austria► SubscribePRODUCT NAME: KOMBINATION AUS OLMESARTAN MEDOXOMIL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, AMLODIPIN BESILAT UND HYDROCHLOROTHIAZID; NAT. REGISTRATION NO/DATE: 1-30068 - 1-30072 20110216; FIRST REGISTRATION: DE 79810.00.00 - 79814.00.00, UND 79815.00.00 - 79819.00.00 20101216
056Luxembourg► Subscribe91056, EXPIRES: 20170221
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
0625Netherlands► 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
2006 00012Denmark► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Merck
Chinese Patent Office
Julphar
Boehringer Ingelheim
Colorcon
AstraZeneca
Mallinckrodt
Fuji
US Department of Justice
Fish and Richardson

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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