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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Queensland Health
Teva
US Army
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Dow
US Department of Justice
Farmers Insurance
Daiichi Sankyo
Cerilliant

Generated: September 25, 2017

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EDARBI Drug Profile

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What is the patent landscape for Edarbi, and when can generic versions of Edarbi launch?

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

This drug has seventy-one patent family members in thirty-four countries.

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

Summary for Tradename: EDARBI

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list40
Clinical Trials: see list15
Patent Applications: see list66
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:EDARBI at DailyMed

Pharmacology for Tradename: EDARBI

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
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: EDARBI

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 2011► Subscribe► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 2011► Subscribe► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 2011► Subscribe► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 2011► Subscribe► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 2011► Subscribe► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 2011► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: EDARBI

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,875,637Benzimidazole derivative and use as a II receptor antagonist► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: EDARBI

Country Document Number Estimated Expiration
Argentina094588► Subscribe
World Intellectual Property Organization (WIPO)2005080384► Subscribe
Israel201188► Subscribe
CroatiaP20090593► Subscribe
BrazilPI0507984► Subscribe
Norway2012017► Subscribe
Mexico2009010167► Subscribe
Denmark2119715► Subscribe
Serbia50537► Subscribe
European Patent Office2119715► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: EDARBI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1 5004-2012Slovakia► SubscribePRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/735/011 20111207
962Luxembourg► Subscribe91962, EXPIRES: 20261207
6Finland► Subscribe
C0034France► SubscribePRODUCT NAME: AZILSARTAN MEDOXOMIL ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/735/001 20111207
12/008Ireland► SubscribePRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTRATION NO/DATE: EU/1/11/734/001-011 EU/1/11/735/001-011 20111209
0802Netherlands► SubscribePRODUCT NAME: AZILSARTAN MEDOXOMIL EN CHLOORTALIDON; NATIONAL REGISTRATION NO/DATE: RVG116387 20151125; FIRST REGISTRATION: CH 6314502 20141028
C/GB12/028United Kingdom► SubscribePRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
2012004Lithuania► SubscribePRODUCT 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
2012004,C1718641Lithuania► SubscribePRODUCT 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
1718641/01Switzerland► SubscribePRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Cantor Fitzgerald
Express Scripts
AstraZeneca
Teva
Colorcon
Boehringer Ingelheim
Harvard Business School
Farmers Insurance
UBS

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.

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