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Last Updated: March 19, 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-001 Dec 20, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-002 Feb 25, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-001 Dec 20, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Lupin Ltd AZILSARTAN MEDOXOMIL azilsartan kamedoxomil TABLET;ORAL 214489-002 Jul 20, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-002 Feb 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-002 Feb 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-002 Feb 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for azilsartan kamedoxomil

Country Patent Number Title Estimated Expiration
Norway 332344 ⤷  Try a Trial
Hong Kong 1098472 Benzimidazole derivative and its use as a II receptor antagonist ⤷  Try a Trial
Denmark 1857457 ⤷  Try a Trial
Japan 2005272451 BENZIMIDAZOLE DERIVATIVE AND ITS USE ⤷  Try a Trial
Brazil 122012009489 processo para produzir 2-etóxi-1-{[2 -(5-oxo-4,5-diidro-1,2,4-oxadiazol-3-il)bifenil-4-il]metil}-1h-benzimidazol-7-carboxilato de (5-metil-2-oxo-1,3-dioxol-4-il)metila ou um sal do mesmo, composição farmacéutica, e, uso ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for azilsartan kamedoxomil

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1718641 PA2012004,C1718641 Lithuania ⤷  Try a 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 121 5004-2012 Slovakia ⤷  Try a Trial PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/735/011 20111207
1718641 1290016-3 Sweden ⤷  Try a Trial PRODUCT NAME: AZILSARTANMEDOXOMIL OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV, INKLUDERANDE KALIUMSALT; REG. NO/DATE: EU/1/11/735/001 20111207
1718641 C01718641/01 Switzerland ⤷  Try a Trial PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
1718641 PA2012004 Lithuania ⤷  Try a 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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