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Last Updated: March 19, 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 freedom to operate?

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 202331-002 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
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 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
>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
Norway 332344 ⤷  Try a Trial
Colombia 6341633 COMPOSICION FARMACEUTICA SOLIDA ⤷  Try a Trial
Mexico 2011001150 COMPOSICION FARMACEUTICA SOLIDA. (SOLID PHARMACEUTICAL COMPOSITION.) ⤷  Try a Trial
Japan 2011529444 ⤷  Try a Trial
Hong Kong 1098472 Benzimidazole derivative and its use as a II receptor antagonist ⤷  Try a Trial
Denmark 1857457 ⤷  Try a Trial
Peru 20110551 COMPOSICION FARMACEUTICA SOLIDA QUE CONTIENE UN DERIVADO DE BENCIMIDAZOL Y UN DIURETICO ⤷  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 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
1718641 132012902056823 Italy ⤷  Try a Trial PRODUCT NAME: AZILSARTAN MEDOXOMIL(EDARBI E IPREZIV); AUTHORISATION NUMBER(S) AND DATE(S): EDARBI: DA EU/1/11/734/001 A EU/1/11/734/011; IPREZIV: DA EU/1/11/735/001 A EU/1/11/735/011, 20111207
1718641 2012C/025 Belgium ⤷  Try a Trial PRODUCT NAME: AZILSARTAN MEDOXOMIL; AUTHORISATION NUMBER AND DATE: EU/1/11/734/001 20111209
>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.