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Last Updated: March 19, 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. Thirteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cosette BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532-002 Jun 5, 2003 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-003 Apr 25, 2002 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-004 Apr 25, 2002 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cosette BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532-005 Jun 5, 2003 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cosette BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532-003 Jun 5, 2003 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-001 Apr 25, 2002 ⤷  Try a Trial ⤷  Try a Trial
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-004 Apr 25, 2002 ⤷  Try a Trial ⤷  Try a Trial
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-004 Apr 25, 2002 ⤷  Try a Trial ⤷  Try a Trial
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-003 Apr 25, 2002 ⤷  Try a Trial ⤷  Try a Trial
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-001 Apr 25, 2002 ⤷  Try a Trial ⤷  Try a Trial
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-003 Apr 25, 2002 ⤷  Try a Trial ⤷  Try a Trial
>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
Greece 3035624 ⤷  Try a Trial
Luxembourg 91847 ⤷  Try a Trial
New Zealand 247750 4-CARBOXYIMIDAZOLE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS THEREOF ⤷  Try a Trial
Netherlands 300375 ⤷  Try a Trial
South Africa 9201298 ⤷  Try a Trial
Norway 304517 ⤷  Try a Trial
Denmark 0503785 ⤷  Try a Trial
>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 ⤷  Try a Trial 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 ⤷  Try a Trial 91571, EXPIRES: 20170221
0503785 C00503785/02 Switzerland ⤷  Try a Trial FORMER OWNER: SANKYO COMPANY LIMITED, JP
0503785 C00503785/03 Switzerland ⤷  Try a Trial FORMER REPRESENTATIVE: BOHEST AG, CH
0503785 03C0037 France ⤷  Try a Trial PRODUCT NAME: OLMESARTAN MEDOXOMIL; NAT. REGISTRATION NO/DATE: NL28292 20030806; FIRST REGISTRATION: DE - 50202.00 20020813
0503785 9/2011 Austria ⤷  Try a Trial 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
0503785 C300133 Netherlands ⤷  Try a Trial PRODUCT NAME: OLMESARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN DE CARBOXYGROEP GEKOZEN UIT DE VOLGENDE : EEN ALKYLGROEP 1-4 KOOLSTOFATOMEN, EEN BENZYLGROEP, EEN ALKANOYLOXYALKYLGROEP WAARIN HET ALKANOYLDEEL 1-5; NATL. REGISTRATION NO/DATE: RVG 28785-RVG 28787 20030527; FIRST REGISTRATION: DE 502.02.00.00,502.02.01.00, 502.02.02.00 20020813
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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