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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Harvard Business School
Queensland Health
Federal Trade Commission
AstraZeneca
Healthtrust
Accenture
Chubb
McKesson
McKinsey

Generated: December 12, 2017

DrugPatentWatch Database Preview

BENICAR HCT Drug Profile

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

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

This drug has one hundred and one patent family members in twenty-seven countries and twenty-six supplementary protection certificates in eight countries.

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

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Daiichi SankyoBENICAR HCThydrochlorothiazide; olmesartan medoxomilTABLET;ORAL021532-002Jun 5, 2003ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Daiichi SankyoBENICAR HCThydrochlorothiazide; olmesartan medoxomilTABLET;ORAL021532-003Jun 5, 2003ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Daiichi SankyoBENICAR HCThydrochlorothiazide; olmesartan medoxomilTABLET;ORAL021532-005Jun 5, 2003ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: BENICAR HCT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi SankyoBENICAR HCThydrochlorothiazide; olmesartan medoxomilTABLET;ORAL021532-002Jun 5, 2003► Subscribe► Subscribe
Daiichi SankyoBENICAR HCThydrochlorothiazide; olmesartan medoxomilTABLET;ORAL021532-005Jun 5, 2003► Subscribe► Subscribe
Daiichi SankyoBENICAR HCThydrochlorothiazide; olmesartan medoxomilTABLET;ORAL021532-003Jun 5, 2003► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
China1189490► Subscribe
Czech Republic289244► Subscribe
Taiwan228521► Subscribe
Ireland970752► Subscribe
China1045770► Subscribe
Finland920749► Subscribe
Czech Republic9301050► Subscribe
Netherlands300133► Subscribe
Israel105825► Subscribe
Norway2009019► 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
0133Netherlands► Subscribe300133, 20120221, EXPIRES: 20170220
C0025Belgium► SubscribePRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
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
330Luxembourg► SubscribeCERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS)
00095Netherlands► SubscribePRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
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
C0009Belgium► SubscribePRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
571Luxembourg► Subscribe91571, EXPIRES: 20170221
C0030France► SubscribePRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
847Luxembourg► Subscribe91847, EXPIRES: 20170221
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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Julphar
Harvard Business School
Baxter
Queensland Health
Farmers Insurance
US Army
Citi
Chinese Patent Office
Fuji
Express Scripts

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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