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Last Updated: November 7, 2024

Azilsartan kamedoxomil - Generic Drug Details


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What are the generic sources for azilsartan kamedoxomil and what is the scope of patent protection?

Azilsartan kamedoxomil is the generic ingredient in three branded drugs marketed by Lupin Ltd and Azurity, and is included in three NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Azilsartan kamedoxomil has eighty-nine patent family members in thirty-six countries.

There are three drug master file entries for azilsartan kamedoxomil. One supplier is listed for this compound.

Summary for azilsartan kamedoxomil
Pharmacology for azilsartan kamedoxomil
Paragraph IV (Patent) Challenges for AZILSARTAN KAMEDOXOMIL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EDARBI Tablets azilsartan kamedoxomil 40 mg and 80 mg 200796 1 2020-04-10

US Patents and Regulatory Information for azilsartan kamedoxomil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-002 Feb 25, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-001 Dec 20, 2011 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  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 azilsartan kamedoxomil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-002 Feb 25, 2011 ⤷  Sign Up ⤷  Sign Up
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-002 Feb 25, 2011 ⤷  Sign Up ⤷  Sign Up
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011 ⤷  Sign Up ⤷  Sign Up
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011 ⤷  Sign Up ⤷  Sign Up
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-002 Feb 25, 2011 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for azilsartan kamedoxomil

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1718641 12C0034 France ⤷  Sign Up PRODUCT NAME: AZILSARTAN MEDOXOMIL ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/735/001 20111207
1718641 C 2012 017 Romania ⤷  Sign Up PRODUCT NAME: AZILSARTAN MEDOXOMIL SI SARURI ACCEPTABILE FARMACEUTICALE ACESTUIA, INCLUZAND SAREA DEUTHORISATION: 20111207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/ POTASIU; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/734/001 - RO EU/1/11/734/011; DATE OF NATIONAL A734/001 - EMEA EU/1/11/734/011; DATE OF FIRST AUTHORISATION IN EEA: 20111207
1718641 CA 2012 00013 Denmark ⤷  Sign Up
1718641 121 5004-2012 Slovakia ⤷  Sign Up PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/735/011 20111207
1718641 2012/008 Ireland ⤷  Sign Up PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTRATION NO/DATE: EU/1/11/734/001-011 EU/1/11/735/001-011 20111209
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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