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Last Updated: November 24, 2024

BENICAR Drug Patent Profile


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When do Benicar patents expire, and what generic alternatives are available?

Benicar is a drug marketed by Cosette and is included in two NDAs.

The generic ingredient in BENICAR 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.

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Drug patent expirations by year for BENICAR
Drug Prices for BENICAR

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Drug Sales Revenue Trends for BENICAR

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Recent Clinical Trials for BENICAR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
EMSPhase 3
Daiichi Sankyo Co., Ltd.N/A
Chinese PLA General HospitalPhase 4

See all BENICAR clinical trials

Pharmacology for BENICAR
Paragraph IV (Patent) Challenges for BENICAR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BENICAR Tablets olmesartan medoxomil 5 mg, 20 mg and 40 mg 021286 1 2006-04-25

US Patents and Regulatory Information for BENICAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-001 Apr 25, 2002 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cosette BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532-002 Jun 5, 2003 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-003 Apr 25, 2002 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-001 Apr 25, 2002 ⤷  Sign Up ⤷  Sign Up
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-003 Apr 25, 2002 ⤷  Sign Up ⤷  Sign Up
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-004 Apr 25, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for BENICAR

See the table below for patents covering BENICAR around the world.

Country Patent Number Title Estimated Expiration
Norway 304516 ⤷  Sign Up
Taiwan 228521 ⤷  Sign Up
Russian Federation 2086541 ПРОИЗВОДНЫЕ ИМИДАЗОЛА ИЛИ ИХ ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМЫЕ СЛОЖНЫЕ ЭФИРЫ И СПОСОБ ИХ ПОЛУЧЕНИЯ (IMIDAZOLE DERIVATIVES OR THEIR PHARMACEUTICALLY ACCEPTABLE ESTERS AND A METHOD OF THEIR SYNTHESIS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BENICAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0503785 91847 Luxembourg ⤷  Sign Up 91847, EXPIRES: 20170221
0503785 C300486 Netherlands ⤷  Sign Up PRODUCT 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
0503785 CA 2011 00026 Denmark ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.