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Last Updated: August 5, 2020

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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 two branded drugs marketed by Arbor Pharms Llc and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for azilsartan kamedoxomil
International Patents:88
US Patents:5
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 6
Suppliers / Packagers: 1
Bulk Api Vendors: 87
Patent Applications: 143
DailyMed Link:azilsartan kamedoxomil at DailyMed
Pharmacology for azilsartan kamedoxomil
Paragraph IV (Patent) Challenges for AZILSARTAN KAMEDOXOMIL
Tradename Dosage Ingredient NDA Submissiondate
EDARBI TABLET;ORAL azilsartan kamedoxomil 200796 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
Arbor Pharms Llc EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011 RX Yes No   Start Trial   Start Trial Y   Start Trial
Arbor Pharms Llc EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Arbor Pharms Llc EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start 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 azilsartan kamedoxomil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Arbor Pharms Llc EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-002 Feb 25, 2011   Start Trial   Start Trial
Arbor Pharms Llc EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011   Start Trial   Start Trial
Arbor Pharms Llc EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011   Start Trial   Start Trial
>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 C 2012 017 Romania   Start Trial PRODUCT NAME: AZILSARTAN MEDOXOMIL SI SARURI ACCEPTABILE FARMACEUTICALE ACESTUIA, INCLUZAND SAREA DE POTASIU; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/734/001 - RO EU/1/11/734/011; DATE OF NATIONAL AUTHORISATION: 20111207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/734/001 - EMEA EU/1/11/734/011; DATE OF FIRST AUTHORISATION IN EEA: 20111207
1718641 132012902056823 Italy   Start Trial PRODUCT NAME: AZILSARTAN MEDOXOMIL(EDARBI E IPREZIV); AUTHORISATION NUMBER(S) AND DATE(S): EDARBI: DA EU/1/11/734/001 A EU/1/11/734/011; IPREZIV: DA EU/1/11/735/001 A EU/1/11/735/011, 20111207
1718641 PA2012004 Lithuania   Start Trial PRODUCT NAME: AZILSARTANUM MEDOXOMILUM; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/734/011, 2011 12 07, EU/1/11/735/001 - EU/1/11/735/011 20111207
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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