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Serving leading biopharmaceutical companies globally:

McKesson
Chinese Patent Office
Fish and Richardson
Colorcon
Medtronic
Fuji
UBS
Baxter
Teva
Deloitte

Generated: October 21, 2017

DrugPatentWatch Database Preview

BENICAR Drug Profile

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Which patents cover Benicar, and when can generic versions of Benicar launch?

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 one hundred and one patent family members in twenty-seven countries and nineteen supplementary protection certificates in seven countries.

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

Summary for Tradename: BENICAR

US 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, 2002ABRXYesNo► Subscribe► Subscribe ► Subscribe
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-002Jun 5, 2003ABRXYesNo► Subscribe► Subscribe ► Subscribe
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-003Apr 25, 2002ABRXYesNo► Subscribe► Subscribe ► Subscribe
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-004Apr 25, 2002ABRXYesYes► Subscribe► Subscribe ► Subscribe
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-005Jun 5, 2003ABRXYesYes► Subscribe► Subscribe ► Subscribe
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-003Jun 5, 2003ABRXYesNo► Subscribe► 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, 2002► Subscribe► Subscribe
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-004Apr 25, 2002► Subscribe► Subscribe
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-003Apr 25, 2002► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
Israel114996► Subscribe
Iceland3819► Subscribe
Luxembourg91330► Subscribe
JapanH07121918► Subscribe
Czech Republic287764► Subscribe
Canada2097444► Subscribe
Norway2009019► Subscribe
Czech Republic9301050► Subscribe
HungaryT64329► Subscribe
Australia661153► 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
0133Netherlands► Subscribe300133, 20120221, EXPIRES: 20170220
C0037France► SubscribePRODUCT NAME: OLMESARTAN MEDOXOMIL; NAT. REGISTRATION NO/DATE: NL28292 20030806; FIRST REGISTRATION: DE - 50202.00 20020813
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
330Luxembourg► SubscribeCERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS)
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
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
0503785/01Switzerland► SubscribeFORMER OWNER: SANKYO COMPANY LIMITED, JP
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
571Luxembourg► Subscribe91571, EXPIRES: 20170221
0503785/04Switzerland► 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 leading biopharmaceutical companies globally:

AstraZeneca
Chinese Patent Office
Cipla
Fuji
McKesson
Novartis
UBS
US Department of Justice
Dow
Cerilliant

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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