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Serving 500+ biopharmaceutical companies globally:

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Federal Trade Commission
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Generated: June 24, 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 Prinston Inc, Torrent Pharms Ltd, Mylan Pharms Inc, Daiichi Sankyo, Teva Pharms Usa, Alembic Pharms Ltd, and Aurobindo Pharma Ltd, and is included in seven NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Hydrochlorothiazide; olmesartan medoxomil has ninety-eight patent family members in twenty-seven countries.

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

Summary for Generic Name: hydrochlorothiazide; olmesartan medoxomil

Tradenames:2
Patents:2
Applicants:7
NDAs:7
Drug Master File Entries: see list31
Suppliers / Packagers: see list13
Clinical Trials: see list395
Drug Prices:see low prices
DailyMed Link:hydrochlorothiazide; olmesartan medoxomil at DailyMed

Pharmacology for Ingredient: hydrochlorothiazide; olmesartan medoxomil

Tentative approvals for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe20MG;12.5MGTABLET;ORAL
► Subscribe► Subscribe40MG;25MGTABLET;ORAL
► Subscribe► Subscribe40MG;12.5MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL078827-001Oct 26, 2016ABRXNoNo► Subscribe► Subscribe
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-003Jun 5, 2003ABRXYesNo5,616,599*PED► Subscribe ► Subscribe
Aurobindo Pharma Ltd
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL205391-001Apr 24, 2017ABRXNoNo► Subscribe► Subscribe
Alembic Pharms Ltd
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL204233-001Apr 24, 2017ABRXNoNo► Subscribe► Subscribe
Teva Pharms Usa
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL200532-001Apr 24, 2017ABRXNoNo► 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 Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-002Jun 5, 20035,616,599*PED► Subscribe
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-005Jun 5, 20035,616,599*PED► Subscribe
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-003Jun 5, 20035,616,599*PED► 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
Australia661153► Subscribe
Canada2097444► Subscribe
HungaryT64329► Subscribe
Norway920688► Subscribe
Germany10299043► 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
056Luxembourg► Subscribe91056, EXPIRES: 20170221
0503785/02Switzerland► SubscribeFORMER OWNER: SANKYO COMPANY LIMITED, JP
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
847Luxembourg► Subscribe91847, EXPIRES: 20170221
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Daiichi Sankyo
Healthtrust
Boehringer Ingelheim
Fuji
McKesson
Moodys
QuintilesIMS
UBS
Johnson and Johnson

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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