AZILSARTAN KAMEDOXOMIL - Generic Drug Details

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What are the generic drug sources for azilsartan kamedoxomil and what is the scope of patent protection?

Azilsartan kamedoxomil is the generic ingredient in three branded drugs marketed by Lupin Ltd and Azurity, and is included in three NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Azilsartan kamedoxomil has eighty-nine patent family members in thirty-six countries.

There are three drug master file entries for azilsartan kamedoxomil. One supplier is listed for this compound.

Summary for AZILSARTAN KAMEDOXOMIL

International Patents:	89
US Patents:	5
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Patent Applications:	798
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AZILSARTAN KAMEDOXOMIL
What excipients (inactive ingredients) are in AZILSARTAN KAMEDOXOMIL?	AZILSARTAN KAMEDOXOMIL excipients list
DailyMed Link:	AZILSARTAN KAMEDOXOMIL at DailyMed

Pharmacology for AZILSARTAN KAMEDOXOMIL

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 AZILSARTAN KAMEDOXOMIL

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 AZILSARTAN KAMEDOXOMIL

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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
Lupin Ltd	AZILSARTAN MEDOXOMIL	azilsartan kamedoxomil	TABLET;ORAL	214489-002	Jul 20, 2022		DISCN	No	No	⤷ 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
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011		RX	Yes	Yes	⤷ 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	200796-002	Feb 25, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Lupin Ltd	AZILSARTAN MEDOXOMIL	azilsartan kamedoxomil	TABLET;ORAL	214489-001	Jul 20, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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 AZILSARTAN KAMEDOXOMIL

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

International Patents for AZILSARTAN KAMEDOXOMIL

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Country	Patent Number	Title	Estimated Expiration
South Korea	20070020411	BENZIMIDAZOLE DERIVATIVE AND USE THEREOF	⤷ Sign Up
Argentina	094588	PROCESO DE OBTENCIÓN DE UN COMPUESTO DERIVADO DE BENZIMIDAZOL Y COMPOSICIÓN FARMACÉUTICA	⤷ Sign Up
Eurasian Patent Organization	016593	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)	⤷ Sign Up
Russian Federation	2369608	ПРОИЗВОДНЫЕ БЕНЗИМИДАЗОЛА И ЕГО ПРИМЕНЕНИЕ (DERIVATIVES OF BENZIMIDAZOLE AND ITS APPLICATION)	⤷ Sign Up
Japan	2010522692		⤷ Sign Up
European Patent Office	1857457	Dérivé de benzimidazole et son utilisation comme antagoniste du récepteur AII (Benzimidazole derivative and its use as AII receptor antagonist)	⤷ Sign Up
Norway	2012017		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for AZILSARTAN KAMEDOXOMIL

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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
1718641	132012902056823	Italy	⤷ Sign Up	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	C20120005 00053	Estonia	⤷ Sign Up	PRODUCT NAME: IPREZIV - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9281 FINAL 07.12.2011
>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.