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Last Updated: November 21, 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
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-004 Apr 25, 2002 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cosette BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532-005 Jun 5, 2003 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cosette BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532-003 Jun 5, 2003 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
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-004 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 021286-001 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
Brazil 0115516 ⤷  Sign Up
Norway 332938 ⤷  Sign Up
Ireland 920540 ⤷  Sign Up
Norway 20032261 ⤷  Sign Up
China 1698603 ⤷  Sign Up
European Patent Office 0503785 Dérivés de 1-biphénylimidazole, leur préparation et leur utilisation thérapeutique (1-Biphenylimidazole derivatives, their preparation and their therapeutic use) ⤷  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 CA 2009 00015 Denmark ⤷  Sign Up 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
0503785 91571 Luxembourg ⤷  Sign Up 91571, EXPIRES: 20170221
0503785 91330 Luxembourg ⤷  Sign Up CERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS)
0503785 C00503785/02 Switzerland ⤷  Sign Up FORMER OWNER: SANKYO COMPANY LIMITED, JP
0503785 03C0037 France ⤷  Sign Up PRODUCT NAME: OLMESARTAN MEDOXOMIL; NAT. REGISTRATION NO/DATE: NL28292 20030806; FIRST REGISTRATION: DE - 50202.00 20020813
0503785 9/2011 Austria ⤷  Sign Up PRODUCT NAME: KOMBINATION AUS OLMESARTAN MEDOXOMIL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, AMLODIPIN BESILAT UND HYDROCHLOROTHIAZID; NAT. REGISTRATION NO/DATE: 1-30068 - 1-30072 20110216; FIRST REGISTRATION: DE 79810.00.00 - 79814.00.00, UND 79815.00.00 - 79819.00.00 20101216
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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