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Last Updated: March 19, 2024

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EDARBI Drug Patent Profile


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Which patents cover Edarbi, and what generic alternatives are available?

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

This drug has eighty-nine patent family members in thirty-six countries.

The generic ingredient in EDARBI is azilsartan kamedoxomil. 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 profile page.

DrugPatentWatch® Generic Entry Outlook for Edarbi

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

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 EDARBI
Drug Prices for EDARBI

See drug prices for EDARBI

Recent Clinical Trials for EDARBI

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

SponsorPhase
Takeda
TakedaPhase 1
TakedaN/A

See all EDARBI clinical trials

Pharmacology for EDARBI
Paragraph IV (Patent) Challenges for EDARBI
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EDARBI Tablets azilsartan kamedoxomil 40 mg and 80 mg 200796 1 2020-04-10

US Patents and Regulatory Information for EDARBI

EDARBI is protected by three US patents.

Patents protecting EDARBI

Benzimidazole derivative and use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-002 Feb 25, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 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 EDARBI

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-002 Feb 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
Azurity EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-002 Feb 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for EDARBI

When does loss-of-exclusivity occur for EDARBI?

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

Argentina

Patent: 5850
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 08235790
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0809522
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 81143
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 08000868
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1677961
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 6593
Estimated Expiration: ⤷  Try a Trial

Patent: 0970896
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 24903
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 83632
Estimated Expiration: ⤷  Try a Trial

Patent: 10522692
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 09010167
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 9851
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 090550
Estimated Expiration: ⤷  Try a Trial

Patent: 130210
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 24903
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 090125846
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 43784
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 15634
Estimated Expiration: ⤷  Try a Trial

Patent: 0902089
Estimated Expiration: ⤷  Try a Trial

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 EDARBI around the world.

Country Patent Number Title Estimated Expiration
Austria 311188 ⤷  Try a Trial
Slovenia 2119715 ⤷  Try a Trial
Japan H0753373 AGENT FOR PREVENTION OR TREATMENT OF ANGIOTENSIN II-MEDIATED DISEASES ⤷  Try a Trial
Germany 69435022 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EDARBI

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
>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.