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Last Updated: April 10, 2020

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BENICAR HCT Drug Profile


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When do Benicar Hct patents expire, and when can generic versions of Benicar Hct launch?

Benicar Hct is a drug marketed by Daiichi Sankyo and is included in one NDA.

The generic ingredient in BENICAR HCT is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two 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.

Drug patent expirations by year for BENICAR HCT
Drug Prices for BENICAR HCT

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Drug Sales Revenue Trends for BENICAR HCT

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Recent Clinical Trials for BENICAR HCT

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SponsorPhase
Chinese PLA General HospitalPhase 4
Torrent Pharmaceuticals LimitedPhase 1
TakedaPhase 3

See all BENICAR HCT clinical trials

Recent Litigation for BENICAR HCT

Identify potential future generic entrants

District Court Litigation
Case NameDate
Handley v. Daiichi Sankyo Inc2020-01-23
Apotex Inc. v. Daiichi Sankyo, Inc.2016-05-16
Aurobindo Pharmaceuticals Limited v. Daiici Sankyo, Inc.2016-05-02

See all BENICAR HCT litigation

Pharmacology for BENICAR HCT
Paragraph IV (Patent) Challenges for BENICAR HCT
Tradename Dosage Ingredient NDA Submissiondate
BENICAR HCT TABLET;ORAL hydrochlorothiazide; olmesartan medoxomil 021532 2007-05-11
BENICAR HCT TABLET;ORAL hydrochlorothiazide; olmesartan medoxomil 021532 2007-02-15

US Patents and Regulatory Information for BENICAR HCT

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 HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532-002 Jun 5, 2003 AB RX Yes No   Start Trial   Start Trial   Start Trial
Daiichi Sankyo BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532-003 Jun 5, 2003 AB RX Yes No   Start Trial   Start Trial   Start Trial
Daiichi Sankyo BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532-005 Jun 5, 2003 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for BENICAR HCT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532-005 Jun 5, 2003   Start Trial   Start Trial
Daiichi Sankyo BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532-002 Jun 5, 2003   Start Trial   Start Trial
Daiichi Sankyo BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532-003 Jun 5, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for BENICAR HCT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0503785 C00503785/01 Switzerland   Start Trial FORMER OWNER: SANKYO COMPANY LIMITED, JP
0503785 C300375 Netherlands   Start Trial 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
0503785 91847 Luxembourg   Start Trial 91847, EXPIRES: 20170221
0503785 C00503785/02 Switzerland   Start Trial FORMER OWNER: SANKYO COMPANY LIMITED, JP
0443983 C00443983/03 Switzerland   Start Trial PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Harvard Business School
Boehringer Ingelheim
Express Scripts
Mallinckrodt
Medtronic

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