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Last Updated: March 28, 2024

Azilsartan kamedoxomil; chlorthalidone - Generic Drug Details


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What are the generic drug 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 202331-001 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
>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 202331-002 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
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-001 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
South Africa 201100871 SOLID PHARMACEUTICAL COMPOSITION ⤷  Try a Trial
European Patent Office 1718641 DERIVES DE BENZIMIDAZOLE ET LEUR UTILISATION COMME ANTAGONISTES DU RECEPTEUR A II (BENZIMIDAZOLE DERIVATIVE AND ITS USE AS A II RECEPTOR ANTAGONIST) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2005080384 ⤷  Try a Trial
Ukraine 103905 ТВЕРДАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ;ТВЕРДА ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ (SOLID PHARMACEUTICAL COMPOSITION) ⤷  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 C20120005 00053 Estonia ⤷  Try a Trial PRODUCT NAME: IPREZIV - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9281 FINAL 07.12.2011
1718641 CA 2012 00013 Denmark ⤷  Try a Trial
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
1718641 C20120004 00052 Estonia ⤷  Try a Trial PRODUCT NAME: EDARBI - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9280 FINAL 07.12.2011
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.