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Last Updated: April 18, 2024

Azilsartan kamedoxomil; chlorthalidone - Generic Drug Details


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What are the generic sources for azilsartan kamedoxomil; chlorthalidone and what is the scope of patent protection?

Azilsartan kamedoxomil; chlorthalidone is the generic ingredient in one branded drug marketed by Azurity and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Azilsartan kamedoxomil; chlorthalidone has one hundred and seventeen patent family members in forty-four countries.

Two suppliers are listed for this compound.

Summary for azilsartan kamedoxomil; chlorthalidone
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for azilsartan kamedoxomil; chlorthalidone
Generic Entry Date for azilsartan kamedoxomil; chlorthalidone*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for azilsartan kamedoxomil; chlorthalidone
Paragraph IV (Patent) Challenges for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EDARBYCLOR Tablets azilsartan kamedoxomil; chlorthalidone 40 mg/12.5 mg and 40 mg/25 mg 202331 1 2022-04-19

US Patents and Regulatory Information for azilsartan kamedoxomil; chlorthalidone

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 202331-002 Dec 20, 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
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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; chlorthalidone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-001 Dec 20, 2011 ⤷  Try a Trial ⤷  Try a Trial
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011 ⤷  Try a Trial ⤷  Try a Trial
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-001 Dec 20, 2011 ⤷  Try a Trial ⤷  Try a Trial
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for azilsartan kamedoxomil; chlorthalidone

Country Patent Number Title Estimated Expiration
Japan 5283632 ⤷  Try a Trial
Spain 2388945 ⤷  Try a Trial
Taiwan 201008915 Solid pharmaceutical composition ⤷  Try a Trial
New Zealand 590948 SOLID PHARMACEUTICAL COMPOSITION COMPRISING A DIURETIC, PH CONTROL AGENT AND AN OXADIAZOLE ⤷  Try a Trial
Canada 2681143 COMPOSITION PHARMACEUTIQUE SOLIDE COMPRENANT UN DERIVE DE BENZIMIDAZOLE-7-CARBOXYLATE ET UN AGENT DE CONTROLE DU PH (SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for azilsartan kamedoxomil; chlorthalidone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 C300525 Netherlands ⤷  Try a Trial PRODUCT NAME: AZILSARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCHE AANVAARDBAAR ZOUT, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/11/734/001-011EU/1/11/735/001-011 2011071207
2119715 300802 Netherlands ⤷  Try a Trial PRODUCT NAME: AZILSARTAN MEDOXOMIL EN CHLOORTALIDON; NATIONAL REGISTRATION NO/DATE: RVG116387 20151125; FIRST REGISTRATION: CH 6314502 20141028
1718641 12C0034 France ⤷  Try a Trial PRODUCT NAME: AZILSARTAN MEDOXOMIL ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/735/001 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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