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Last Updated: March 28, 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 021286-001 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 021286-003 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
Netherlands 300133 ⤷  Try a Trial
Germany 122005000051 ⤷  Try a Trial
Israel 114996 ⤷  Try a Trial
Czech Republic 9200516 ⤷  Try a Trial
Luxembourg 91847 ⤷  Try a Trial
Israel 101034 1-Biphenylimidazole derivatives processes for the preparation thereof and pharmaceutical compositions containing the same ⤷  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 91330 Luxembourg ⤷  Try a Trial CERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS)
0503785 300133 Netherlands ⤷  Try a Trial 300133, 20120221, EXPIRES: 20170220
0503785 03C0037 France ⤷  Try a Trial PRODUCT NAME: OLMESARTAN MEDOXOMIL; NAT. REGISTRATION NO/DATE: NL28292 20030806; FIRST REGISTRATION: DE - 50202.00 20020813
0503785 CA 2006 00012 Denmark ⤷  Try a Trial
0503785 20/2009 Austria ⤷  Try a Trial 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
0503785 C00503785/02 Switzerland ⤷  Try a Trial FORMER OWNER: SANKYO COMPANY LIMITED, JP
>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.