.

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

BENICAR Drug Profile

« Back to Dashboard
Benicar is a drug marketed by Daiichi Sankyo and is included in two NDAs. It is available from nine suppliers. There are two patents protecting this drug and three Paragraph IV challenges.

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

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

Summary for Tradename: BENICAR

Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: see list9

Pharmacology for Tradename: BENICAR

Clinical Trials for: BENICAR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-001Apr 25, 2002RXNo6,878,703*PED<disabled>Y<disabled>
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-002Jun 5, 2003RXNo6,878,703*PED<disabled>Y<disabled>
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286-003Apr 25, 2002RXNo5,616,599*PED<disabled>Y<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: BENICAR

Country Document Number Estimated Expiration
Germany122011000011<disabled in preview>
China1065063<disabled in preview>
Czech Republic287764<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: BENICAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2009 00015Denmark<disabled>PRODUCT 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
00375Netherlands<disabled>PRODUCT 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
056Luxembourg<disabled>91056, EXPIRES: 20170221
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

`abc