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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
QuintilesIMS
Novartis
UBS
Teva
Medtronic
McKesson
Daiichi Sankyo
Argus Health
Express Scripts

Generated: December 11, 2017

DrugPatentWatch Database Preview

Hydrochlorothiazide; olmesartan medoxomil - Generic Drug Details

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What are the generic sources for hydrochlorothiazide; olmesartan medoxomil and what is the scope of hydrochlorothiazide; olmesartan medoxomil freedom to operate?

Hydrochlorothiazide; olmesartan medoxomil
is the generic ingredient in two branded drugs marketed by Daiichi Sankyo, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Mylan Pharms Inc, Prinston Inc, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in seven NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Hydrochlorothiazide; olmesartan medoxomil has one hundred and one patent family members in twenty-seven countries and twenty-six supplementary protection certificates in eight countries.

There are thirty-one drug master file entries for hydrochlorothiazide; olmesartan medoxomil. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for hydrochlorothiazide; olmesartan medoxomil

Pharmacology for hydrochlorothiazide; olmesartan medoxomil

Tentative approvals for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Applicant Application No. Strength Dosage Form
u► Subscribe20MG;12.5MGTABLET;ORAL
u► Subscribe40MG;25MGTABLET;ORAL
u► Subscribe40MG;12.5MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Torrent Pharms LtdOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; olmesartan medoxomilTABLET;ORAL206515-002May 3, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Teva Pharms UsaOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; olmesartan medoxomilTABLET;ORAL200532-002Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Daiichi SankyoBENICAR HCThydrochlorothiazide; olmesartan medoxomilTABLET;ORAL021532-002Jun 5, 2003ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; olmesartan medoxomilTABLET;ORAL078827-001Oct 26, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Teva Pharms UsaOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; olmesartan medoxomilTABLET;ORAL200532-003Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Prinston IncOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; olmesartan medoxomilTABLET;ORAL207804-001Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Prinston IncOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; olmesartan medoxomilTABLET;ORAL207804-003Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Torrent Pharms LtdOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; olmesartan medoxomilTABLET;ORAL206515-001May 3, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; olmesartan medoxomilTABLET;ORAL205391-001Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Teva Pharms UsaOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; olmesartan medoxomilTABLET;ORAL200532-001Apr 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: hydrochlorothiazide; olmesartan medoxomil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi SankyoBENICAR HCThydrochlorothiazide; olmesartan medoxomilTABLET;ORAL021532-002Jun 5, 2003► Subscribe► Subscribe
Daiichi SankyoBENICAR HCThydrochlorothiazide; olmesartan medoxomilTABLET;ORAL021532-005Jun 5, 2003► Subscribe► Subscribe
Daiichi SankyoBENICAR HCThydrochlorothiazide; olmesartan medoxomilTABLET;ORAL021532-003Jun 5, 2003► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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: hydrochlorothiazide; olmesartan medoxomil

Country Document Number Estimated Expiration
Denmark0545912► Subscribe
Norway2003009► Subscribe
Russian Federation2128173► Subscribe
JapanH0649036► Subscribe
Norway2011013► Subscribe
Finland932492► Subscribe
HungaryT60475► Subscribe
Greece3035624► Subscribe
China1188645► Subscribe
Norway304516► 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: HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00375Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
0503785/04Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
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
0443983/03Switzerland► SubscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0503785/01Switzerland► SubscribeFORMER OWNER: SANKYO COMPANY LIMITED, JP
/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
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
2009 00015Denmark► SubscribePRODUCT NAME: EN KOMBINATION AF OLMESARTANMEDOXOMIL, EVT. I FORM AF ET FARMACEUTISK ACCEPTABELT SALT OG AMLODIPIN-BESILAT; NAT. REG. NO/DATE: MT 42061, 42062, 42063 20081120; FIRST REG. NO/DATE: NL RVG 100984 20080819
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
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
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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Farmers Insurance
Queensland Health
Federal Trade Commission
Merck
Cerilliant
QuintilesIMS
Express Scripts
Citi
Moodys

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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