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Serving 500+ biopharmaceutical companies globally:

Healthtrust
Accenture
Teva
AstraZeneca
Johnson and Johnson
Argus Health
Harvard Business School
Queensland Health
Cipla
Cantor Fitzgerald

Generated: June 27, 2017

DrugPatentWatch Database Preview

BENICAR Drug Profile

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Which patents cover Benicar, and what generic Benicar alternatives are available?

Benicar is a drug marketed by Daiichi Sankyo and is included in two NDAs. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has ninety-eight patent family members in twenty-seven countries.

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

Summary for Tradename: BENICAR

Patents:1
Applicants:1
NDAs:2
Suppliers / Packagers: see list9
Bulk Api Vendors: see list81
Clinical Trials: see list9
Patent Applications: see list2,557
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:BENICAR at DailyMed

Pharmacology for Tradename: BENICAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-001Apr 25, 2002ABRXYesNo5,616,599*PED► Subscribe ► Subscribe
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-002Jun 5, 2003ABRXYesNo5,616,599*PED► Subscribe ► Subscribe
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-003Apr 25, 2002ABRXYesNo5,616,599*PED► Subscribe ► Subscribe
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-004Apr 25, 2002ABRXYesYes5,616,599*PED► Subscribe ► Subscribe
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-005Jun 5, 2003ABRXYesYes5,616,599*PED► Subscribe ► Subscribe
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Expired Patents for Tradename: BENICAR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-001Apr 25, 20025,616,599*PED► Subscribe
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-004Apr 25, 20025,616,599*PED► Subscribe
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-003Apr 25, 20025,616,599*PED► Subscribe
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Paragraph IV activity for: BENICAR

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
olmesartan medoxomilTablets5 mg, 20 mg and 40 mgBenicar4/25/2006

Non-Orange Book Patents for Tradename: BENICAR

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

Country Document Number Estimated Expiration
Czech Republic9301050► Subscribe
Norway931980► Subscribe
JapanH0649036► Subscribe
Finland920749► Subscribe
Ireland920540► 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0037France► SubscribePRODUCT NAME: OLMESARTAN MEDOXOMIL; NAT. REGISTRATION NO/DATE: NL28292 20030806; FIRST REGISTRATION: DE - 50202.00 20020813
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
2006 00012Denmark► Subscribe
0503785/02Switzerland► SubscribeFORMER OWNER: SANKYO COMPANY LIMITED, JP
0503785/03Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
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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
Covington
Farmers Insurance
Mallinckrodt
Accenture
US Army
Harvard Business School
Chinese Patent Office
McKesson
AstraZeneca

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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