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BENICAR HCT Drug Profile

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Benicar Hct is a drug marketed by Daiichi Sankyo and is included in one NDA. It is available from seven suppliers. There are two patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in BENICAR HCT is hydrochlorothiazide; olmesartan medoxomil. There are thirty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.

Summary for Tradename: BENICAR HCT

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list7
Bulk Api Vendors: see list80
Clinical Trials: see list151
Patent Applications: see list2,406
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:BENICAR HCT at DailyMed

Pharmacology for Tradename: BENICAR HCT

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;ORAL021532-002Jun 5, 2003RXYesNo5,616,599*PED► subscribe ► subscribe
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-003Jun 5, 2003RXYesNo6,878,703*PED► subscribeY► subscribe
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-002Jun 5, 2003RXYesNo6,878,703*PED► subscribeY► subscribe
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Expired Patents for Tradename: BENICAR HCT

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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Paragraph IV activity for: BENICAR HCT

Drugname Dosage Strength RLD Submissiondate
olmesartan medoxomil and hydrochlorothiazideTablets20 mg/12.5 mgBenicar HCT5/11/2007
olmesartan medoxomil and hydrochlorothiazideTablets40 mg/12.5 mg and 40 mg/25 mLBenicar HCT2/15/2007

Non-Orange Book Patents for Tradename: BENICAR HCT

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 Tradename: BENICAR HCT

Country Document Number Estimated Expiration
Denmark0503785► subscribe
Luxembourg91056► subscribe
South Africa9201298► 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: BENICAR HCT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB03/024United Kingdom► subscribePRODUCT NAME: OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHAMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE 50202.00.00 20020813; DE 50202.01.00 20020813; DE 50202.02.00 20020813; DE 50205.00.00 20020813; DE 50205.01.00 20020813; DE 50205.02.00 20020813; UK PL 08265/0015 20030522; UK PL 08265/0016 20030522; UK PL08265/0017 20030522
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
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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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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