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Serving leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
US Department of Justice
Chubb
AstraZeneca
Moodys
Covington
Chinese Patent Office
Fuji
McKesson

Generated: December 12, 2017

DrugPatentWatch Database Preview

BENICAR Drug Profile

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Which patents cover Benicar, and what generic 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 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. 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 SankyoBENICARolmesartan medoxomilTABLET;ORAL021286-001Apr 25, 2002ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Daiichi SankyoBENICAR HCThydrochlorothiazide; olmesartan medoxomilTABLET;ORAL021532-002Jun 5, 2003ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Daiichi SankyoBENICARolmesartan medoxomilTABLET;ORAL021286-003Apr 25, 2002ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Daiichi SankyoBENICARolmesartan medoxomilTABLET;ORAL021286-004Apr 25, 2002ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Daiichi SankyoBENICAR HCThydrochlorothiazide; olmesartan medoxomilTABLET;ORAL021532-005Jun 5, 2003ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Daiichi SankyoBENICAR HCThydrochlorothiazide; olmesartan medoxomilTABLET;ORAL021532-003Jun 5, 2003ABRXYesNo► Subscribe► 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 SankyoBENICARolmesartan medoxomilTABLET;ORAL021286-001Apr 25, 2002► Subscribe► Subscribe
Daiichi SankyoBENICARolmesartan medoxomilTABLET;ORAL021286-004Apr 25, 2002► Subscribe► Subscribe
Daiichi SankyoBENICARolmesartan medoxomilTABLET;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
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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
330Luxembourg► SubscribeCERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS)
C0037France► SubscribePRODUCT NAME: OLMESARTAN MEDOXOMIL; NAT. REGISTRATION NO/DATE: NL28292 20030806; FIRST REGISTRATION: DE - 50202.00 20020813
571Luxembourg► Subscribe91571, EXPIRES: 20170221
0133Netherlands► Subscribe300133, 20120221, EXPIRES: 20170220
847Luxembourg► Subscribe91847, EXPIRES: 20170221
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
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
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
0503785/04Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
/2009Austria► SubscribePRODUCT NAME: KOMBINATION VON OLMESARTAN MEDOXOMIL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, MIT AMLODIPINBESILAT; NAT. REGISTRATION NO/DATE: 1-27894, 1-27895, 1-27896 20081217; FIRST REGISTRATION: NL 100989, 100990, 100991 20080819
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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Accenture
Colorcon
Deloitte
US Department of Justice
Teva
McKesson
Express Scripts
Novartis
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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