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Last Updated: February 26, 2020

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EDARBYCLOR Drug Profile


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Which patents cover Edarbyclor, and when can generic versions of Edarbyclor launch?

Edarbyclor is a drug marketed by Arbor Pharms Llc and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and fifteen patent family members in forty-three countries.

The generic ingredient in EDARBYCLOR is azilsartan kamedoxomil; chlorthalidone. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the azilsartan kamedoxomil; chlorthalidone profile page.

US ANDA Litigation and Generic Entry Outlook for Edarbyclor

Edarbyclor was eligible for patent challenges on February 25, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 4, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for EDARBYCLOR
Drug patent expirations by year for EDARBYCLOR
Drug Prices for EDARBYCLOR

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Generic Entry Opportunity Date for EDARBYCLOR
Generic Entry Date for EDARBYCLOR*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for EDARBYCLOR

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SponsorPhase
TakedaPhase 3

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Synonyms for EDARBYCLOR
Azilsartan kamedoxomil / chlorthalidone
Azilsartan kamedoxomil mixture with chlorthalidone
Azilsartan medoxomil / chlorthalidone
Azilsartan medoxomil mixture with chlorthalidone
S900005855

US Patents and Regulatory Information for EDARBYCLOR

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 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
Arbor Pharms Llc EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-001 Dec 20, 2011 RX Yes No   Start Trial   Start Trial Y   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 EDARBYCLOR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Arbor Pharms Llc EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-001 Dec 20, 2011   Start Trial   Start Trial
Arbor Pharms Llc EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011   Start Trial   Start Trial
Arbor Pharms Llc EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for EDARBYCLOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1718641 91962 Luxembourg   Start Trial 91962, EXPIRES: 20261207
1718641 132012902056823 Italy   Start 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 436 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson

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 verifification 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.