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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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Summary for EDARBI

International Patents:	89
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	15
Patent Applications:	261
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EDARBI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EDARBI
What excipients (inactive ingredients) are in EDARBI?	EDARBI excipients list
DailyMed Link:	EDARBI at DailyMed

Drug patent expirations by year for EDARBI

Recent Clinical Trials for EDARBI

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

Sponsor	Phase
Takeda
Takeda	Phase 1
Takeda	N/A

See all EDARBI clinical trials

Pharmacology for EDARBI

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Type 1 Receptor Antagonists
Physiological Effect	Decreased Blood Pressure

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: ⤷ 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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011		RX	Yes	Yes	⤷ 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 EDARBI

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	⤷ Sign Up	⤷ Sign Up
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011	⤷ Sign Up	⤷ Sign Up
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	⤷ Sign Up	⤷ Sign Up
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011	⤷ Sign Up	⤷ Sign Up
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	⤷ Sign Up	⤷ Sign Up
>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
Patent: COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UN DERIVADO DE BENZIMIDAZOL-7-CARBOXILATO Y UN AGENTE DE CONTROL DE PH
Estimated Expiration: ⤷ Sign Up

Australia

Patent: 08235790
Patent: Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 0809522
Patent: COMPOSIÇÃO FARMACÊUTICA SÓLIDA, MÉTODOS PARA ESTABILIZAR UM COMPOSTO, E PARA MELHORAR DISSOLUÇÃO DE UM COMPOSTO, E, USO DE UM AGENTE DE CONTROLE DE PH.
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 81143
Patent: COMPOSITION PHARMACEUTIQUE SOLIDE COMPRENANT UN DERIVE DE BENZIMIDAZOLE-7-CARBOXYLATE ET UN AGENT DE CONTROLE DU PH (SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT)
Estimated Expiration: ⤷ Sign Up

Chile

Patent: 08000868
Patent: COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UN COMPUESTO DERIVADO DE BENZIMIDAZOL Y UN AGENTE DE CONTROL DE PH; METODO DE ESTABILIZACION Y DE MEJORAMIENTO DE LA DISOLUCION; USO DE UN AGENTE DE CONTROL DE PH.
Estimated Expiration: ⤷ Sign Up

China

Patent: 1677961
Patent: Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a ph control agent
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 6593
Patent: ТВЕРДАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ ПРОИЗВОДНОЕ БЕНЗИМИДАЗОЛ-7-КАРБОКСИЛАТА И pH РЕГУЛИРУЮЩИЙ АГЕНТ (SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT)
Estimated Expiration: ⤷ Sign Up

Patent: 0970896
Patent: ТВЕРДАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ ПРОИЗВОДНОЕ БЕНЗИМИДАЗОЛ-7-КАРБОКСИЛАТА И pH РЕГУЛИРУЮЩИЙ АГЕНТ
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 24903
Patent: COMPOSITION PHARMACEUTIQUE SOLIDE COMPRENANT UN DÉRIVÉ DE BENZIMIDAZOLE-7-CARBOXYLATE ET UN AGENT DE CONTRÔLE DU PH (SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 83632
Estimated Expiration: ⤷ Sign Up

Patent: 10522692
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 09010167
Patent: COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UN DERIVADO DE BENCIMIDAZOL-7-CARBOXILATO Y UN AGENTE PARA EL CONTROL DEL PH. (SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT.)
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 9851
Patent: SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT
Estimated Expiration: ⤷ Sign Up

Peru

Patent: 090550
Patent: COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UN DERIVADO DE BENCIMIDAZOL Y UN AGENTE DE CONTROL DE PH
Estimated Expiration: ⤷ Sign Up

Patent: 130210
Patent: COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UN DERIVADO DE BENCIMIDAZOL Y UN AGENTE DE CONTROL DE PH
Estimated Expiration: ⤷ Sign Up

Portugal

Patent: 24903
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 090125846
Patent: SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 43784
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 15634
Estimated Expiration: ⤷ Sign Up

Patent: 0902089
Patent: Solid pharmaceutical composition
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 EDARBI around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	1859892		⤷ Sign Up
Montenegro	01089	DERIVAT BENZIMIDAZOLA I NJEGOVA UPOTREBA KAO ANTAGONISTA RECEPTORA AII (BENZIMIDAZOLE DERIVATIVE AND ITS USE AS AII RECEPTOR ANTAGONIST)	⤷ Sign Up
Norway	300734		⤷ Sign Up
Argentina	047972	DERIVADO DE BENCIMIDAZOL, PROCESO DE OBTENCION Y COMPOSICIONES FARMACEUTICAS.	⤷ Sign Up
Norway	2012017		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for EDARBI

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1718641	PA2012004	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	C01718641/01	Switzerland	⤷ Sign Up	PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
2119715	2018/006	Ireland	⤷ Sign Up	PRODUCT NAME: COMBINATION OF AZILSARTAN MEDOXOMIL AND CHLORTALIDONE (EDARBYCLOR); NAT REGISTRATION NO/DATE: PA/2167/001/001-002 20170804; FIRST REGISTRATION NO/DATE: 63145 01-02 20141028
1718641	12C0034	France	⤷ Sign Up	PRODUCT NAME: AZILSARTAN MEDOXOMIL ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/735/001 20111207
1718641	C20120004 00052	Estonia	⤷ Sign Up	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