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Hydrochlorothiazide; olmesartan medoxomil - Generic Drug Details

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

Hydrochlorothiazide; olmesartan medoxomil is the generic ingredient in two branded drugs marketed by Mylan Pharms Inc and Daiichi Sankyo, and is included in two NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and twenty-nine patent family members in thirty-one countries.

There are thirty-one drug master file entries for hydrochlorothiazide; olmesartan medoxomil. Eight suppliers are listed for this compound.

Summary for Generic Name: hydrochlorothiazide; olmesartan medoxomil

Tradenames:2
Patents:3
Applicants:2
NDAs:2
Drug Master File Entries: see list31
Suppliers / Packagers: see list8
Clinical Trials: see list107
Drug Prices:see low prices
DailyMed Link:hydrochlorothiazide; olmesartan medoxomil at DailyMed

Pharmacology for Ingredient: hydrochlorothiazide; olmesartan medoxomil

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-003Jun 5, 2003RXYesNo6,878,703*PED► SubscribeY► Subscribe
Mylan Pharms Inc
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL078827-002Oct 26, 2016RXNoNo► Subscribe► Subscribe
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-005Jun 5, 2003RXYesYes5,616,599*PED► Subscribe ► Subscribe
Mylan Pharms Inc
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL078827-001Oct 26, 2016RXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL078827-003Oct 26, 2016RXNoNo► 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
Austria324890► Subscribe
Greece3035906► Subscribe
Japan2003048852► Subscribe
Norway304516► Subscribe
Japan3461863► 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
C/GB02/037United Kingdom► SubscribePRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
0503785/01Switzerland► 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
C0009Belgium► SubscribePRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
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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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