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BENICAR Drug Profile

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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>
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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<disabled in preview>
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International Patent Family for Tradename: BENICAR

Country Document Number Estimated Expiration
Hungary9200578<disabled in preview>
Finland112942<disabled in preview>
JapanH0649036<disabled in preview>
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Supplementary Protection Certificates for Tradename: BENICAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2009Austria<disabled>PRODUCT 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
C0037France<disabled>PRODUCT NAME: OLMESARTAN MEDOXOMIL; NAT. REGISTRATION NO/DATE: NL28292 20030806; FIRST REGISTRATION: DE - 50202.00 20020813
2011 00026Denmark<disabled>PRODUCT 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
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