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Last Updated: May 28, 2024

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EDARBYCLOR Drug Patent Profile


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When do Edarbyclor patents expire, and when can generic versions of Edarbyclor launch?

Edarbyclor is a drug marketed by Azurity and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventeen patent family members in forty-four countries.

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

DrugPatentWatch® 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.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for EDARBYCLOR
Drug Prices for EDARBYCLOR

See drug prices for EDARBYCLOR

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
TakedaPhase 3

See all EDARBYCLOR clinical trials

Paragraph IV (Patent) Challenges for EDARBYCLOR
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 EDARBYCLOR

EDARBYCLOR is protected by five US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of EDARBYCLOR is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting EDARBYCLOR

Benzimidazole derivative and use thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Benzimidazole derivative and use as a II receptor antagonist
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HYPERTENSION

Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Solid pharmaceutical composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods of treating hypertension with at least one angiotensin II receptor blocker and chlorthalidone
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HYPERTENSION

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-001 Dec 20, 2011 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011 ⤷  Sign Up ⤷  Sign Up
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-001 Dec 20, 2011 ⤷  Sign Up ⤷  Sign Up
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for EDARBYCLOR

When does loss-of-exclusivity occur for EDARBYCLOR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 2883
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 09277455
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0916847
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 32018
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 11000187
Estimated Expiration: ⤷  Sign Up

China

Patent: 2164918
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 41633
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 110111
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 011000032
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 11010856
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 1170273
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 10385
Estimated Expiration: ⤷  Sign Up

Georgia, Republic of

Patent: 0146062
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 35491
Estimated Expiration: ⤷  Sign Up

Patent: 11529444
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 11001150
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 553
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 0948
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 110551
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 10385
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1100871
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 110038145
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 1008915
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 11000045
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 3905
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 017
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EDARBYCLOR around the world.

Country Patent Number Title Estimated Expiration
Taiwan I336702 ⤷  Sign Up
Spain 2194009 ⤷  Sign Up
New Zealand 590948 SOLID PHARMACEUTICAL COMPOSITION COMPRISING A DIURETIC, PH CONTROL AGENT AND AN OXADIAZOLE ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EDARBYCLOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1718641 2012C/025 Belgium ⤷  Sign Up PRODUCT NAME: AZILSARTAN MEDOXOMIL; AUTHORISATION NUMBER AND DATE: EU/1/11/734/001 20111209
1718641 PA2012004,C1718641 Lithuania ⤷  Sign Up 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 CA 2012 00013 Denmark ⤷  Sign Up
>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.