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Last Updated: March 4, 2021

DrugPatentWatch Database Preview

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 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 ninety 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:90
US Patents:5
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 6
Suppliers / Packagers: 1
Bulk Api Vendors: 11
Patent Applications: 11
What excipients (inactive ingredients) are in azilsartan kamedoxomil?azilsartan kamedoxomil excipients list
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 200796-002 Feb 25, 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
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 202331-001 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   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 200796-001 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 200796-002 Feb 25, 2011   Start Trial   Start Trial
Arbor Pharms Llc EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011   Start Trial   Start Trial
>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 C20120005 00053 Estonia   Start Trial PRODUCT NAME: IPREZIV - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9281 FINAL 07.12.2011
1718641 436 Finland   Start Trial
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
2119715 300802 Netherlands   Start Trial PRODUCT NAME: AZILSARTAN MEDOXOMIL EN CHLOORTALIDON; NATIONAL REGISTRATION NO/DATE: RVG116387 20151125; FIRST REGISTRATION: CH 6314502 20141028
1718641 PA2012004,C1718641 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
1718641 SPC/GB12/028 United Kingdom   Start Trial PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Express Scripts
Colorcon
McKesson
Johnson and Johnson
Merck

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