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Generated: June 25, 2017

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Azilsartan kamedoxomil; chlorthalidone - Generic Drug Details

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What are the generic sources for azilsartan kamedoxomil; chlorthalidone and what is the scope of azilsartan kamedoxomil; chlorthalidone freedom to operate?

Azilsartan kamedoxomil; chlorthalidone
is the generic ingredient in one branded drug marketed by Arbor Pharms Llc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Azilsartan kamedoxomil; chlorthalidone has ninety-five patent family members in forty countries.

There are five drug master file entries for azilsartan kamedoxomil; chlorthalidone. Two suppliers are listed for this compound.

Summary for Generic Name: azilsartan kamedoxomil; chlorthalidone

Tradenames:1
Patents:4
Applicants:1
NDAs:1
Drug Master File Entries: see list5
Suppliers / Packagers: see list2
Clinical Trials: see list84
Drug Prices:see low prices
DailyMed Link:azilsartan kamedoxomil; chlorthalidone at DailyMed

Pharmacology for Ingredient: azilsartan kamedoxomil; chlorthalidone

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
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-002Dec 20, 2011RXYesYes7,157,584► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-001Dec 20, 2011RXYesNo9,066,936► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-002Dec 20, 2011RXYesYes9,169,238► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-002Dec 20, 2011RXYesYes7,572,920► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-001Dec 20, 2011RXYesNo9,169,238► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: azilsartan kamedoxomil; chlorthalidone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-001Dec 20, 20115,583,141► Subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-002Dec 20, 20115,736,555► Subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-002Dec 20, 20115,583,141► Subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-001Dec 20, 20115,736,555► Subscribe
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Non-Orange Book Patents for Generic Ingredient: azilsartan kamedoxomil; chlorthalidone

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 Ingredient: azilsartan kamedoxomil; chlorthalidone

Country Document Number Estimated Expiration
Japan2010522692► Subscribe
Russian Federation2009115498► Subscribe
Luxembourg91962► Subscribe
Cyprus1107008► Subscribe
Taiwan200530227► 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: AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1718641/01Switzerland► SubscribePRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
1 5004-2012Slovakia► SubscribePRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/735/011 20111207
C0034France► SubscribePRODUCT NAME: AZILSARTAN MEDOXOMIL ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/735/001 20111207
6Finland► Subscribe
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Express Scripts
Cantor Fitzgerald
Daiichi Sankyo
McKinsey
QuintilesIMS
Harvard Business School
Colorcon
Dow
Federal Trade Commission
McKesson

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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