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Last Updated: November 22, 2024

AZILSARTAN KAMEDOXOMIL - Generic Drug Details


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What are the generic drug 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 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
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 202331-002 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 200796-001 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 200796-002 Feb 25, 2011 ⤷  Sign Up ⤷  Sign Up
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for AZILSARTAN KAMEDOXOMIL

Country Patent Number Title Estimated Expiration
Slovenia 1718641 ⤷  Sign Up
Brazil PI0507984 composto ou um sal do mesmo, processo para produzir um composto, medicamento, métodos para antagonizar angiotensina ii em um mamìfero, para melhorar a resistência de insulina em um mamìfero e para prevenir ou tratar doenças circulatórias em um mamìfero, e, uso do composto ⤷  Sign Up
Hungary S1200008 ⤷  Sign Up
Spain 2331209 ⤷  Sign Up
Portugal 1857457 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AZILSARTAN KAMEDOXOMIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1718641 C01718641/01 Switzerland ⤷  Sign Up PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
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
2119715 2018/006 Ireland ⤷  Sign Up PRODUCT NAME: COMBINATION OF AZILSARTAN MEDOXOMIL AND CHLORTALIDONE (EDARBYCLOR); NAT REGISTRATION NO/DATE: PA/2167/001/001-002 20170804; FIRST REGISTRATION NO/DATE: 63145 01-02 20141028
1718641 91962 Luxembourg ⤷  Sign Up 91962, EXPIRES: 20261207
1718641 2012C/025 Belgium ⤷  Sign Up PRODUCT NAME: AZILSARTAN MEDOXOMIL; AUTHORISATION NUMBER AND DATE: EU/1/11/734/001 20111209
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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