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Last Updated: December 6, 2019

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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 freedom to operate?

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-five 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:85
US Patents:5
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 6
Suppliers / Packagers: 1
Bulk Api Vendors: 84
Patent Applications: 143
DailyMed Link:AZILSARTAN KAMEDOXOMIL at DailyMed
Pharmacology for AZILSARTAN KAMEDOXOMIL
Synonyms for AZILSARTAN KAMEDOXOMIL
1H-Benzimidazole-7-carboxylic acid, 1-((2'-(2,5-dihydro-5-oxo-1,2,4-oxadiazol-3- yl)(1,1'-biphenyl)-4-yl)methyl)-2-ethoxy-, (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl ester, potassium salt
863031-24-7
AC-26396
AKOS025401854
AKOS027326629
Azilsartan (medoxomil monopotassium)
Azilsartan kamedoxomil (USAN)
Azilsartan kamedoxomil [USAN]
Azilsartan medoxomil potassium
BCP11249
CHEBI:68847
CHEMBL2103795
CS-2153
D08865
DTXSID70235483
FT-0686729
HY-17458
MolPort-042-694-232
Potassium 3-(4'-((2-ethoxy-7-(((5-methyl-2-oxo-1,3-dioxol-4-yl)methoxy)carbonyl)-1H-benzimidazol-1-yl)methyl)biphenyl-2-yl)-5-oxo-1,2,4-oxadiazol-4(5H)-ide
Potassium 3-(4'-((2-ethoxy-7-(((5-methyl-2-oxo-1,3-dioxol-4-yl)methoxy)carbonyl)-1H-benzo[d]imidazol-1-yl)methyl)-[1,1'-biphenyl]-2-yl)-5-oxo-5H-1,2,4-oxadiazol-2-ide
potassium 3-{4'-[(2-ethoxy-7-{[(5-methyl-2-oxo-1,3-dioxol-4-yl)methoxy]carbonyl}-1H-benzimidazol-1-yl)methyl]biphenyl-2-yl}-5-oxo-1,2,4-oxadiazol-4-ide
Potassium,(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-3-[[4-[2-(5-oxo-1-oxa-2-aza-4-azanidacyclopent-2-en-3-yl)phenyl]phenyl]methyl]benzimidazole-4-carboxylate
SB19561
SCHEMBL967310
TAK-491
UNII-WEC6I2K1FC
WEC6I2K1FC

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 200796-002 Feb 25, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
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 202331-001 Dec 20, 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   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 200796-002 Feb 25, 2011   Start Trial   Start Trial
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 91962 Luxembourg   Start Trial 91962, EXPIRES: 20261207
1718641 CA 2012 00013 Denmark   Start Trial
2119715 2018/006 Ireland   Start Trial 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 C01718641/01 Switzerland   Start Trial PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
1718641 436 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Colorcon
Merck
Mallinckrodt
Johnson and Johnson

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