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Azilsartan kamedoxomil - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for azilsartan kamedoxomil?

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

This ingredient has sixty-nine patent family members in thirty-two countries.

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

Summary for Generic Name: azilsartan kamedoxomil

Tradenames:2
Patents:4
Applicants:1
NDAs:2
Drug Master File Entries: see list5
Suppliers / Packagers: see list2
Bulk Api Vendors: see list43
Clinical Trials: see list39
Patent Applications: see list27
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:azilsartan kamedoxomil at DailyMed

Pharmacology for Ingredient: azilsartan kamedoxomil

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-001Dec 20, 2011RXYesNo7,572,920► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 2011RXYesNo9,066,936► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-001Dec 20, 2011RXYesNo7,157,584► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-001Dec 20, 2011RXYesNo9,169,238► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-002Dec 20, 2011RXYesYes9,066,936► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: azilsartan kamedoxomil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 20115,583,141► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 20115,958,961► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 20115,958,961► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 20115,736,555► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 20115,583,141► Subscribe
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Non-Orange Book Patents for Generic Ingredient: azilsartan kamedoxomil

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

Country Document Number Estimated Expiration
Argentina094588► Subscribe
BrazilPI0809522► Subscribe
Australia2005214271► Subscribe
Slovenia1857457► Subscribe
Russian Federation2501798► 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0034France► SubscribePRODUCT NAME: AZILSARTAN MEDOXOMIL ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/735/001 20111207
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
90016-3Sweden► SubscribePRODUCT NAME: AZILSARTANMEDOXOMIL OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV, INKLUDERANDE KALIUMSALT; REG. NO/DATE: EU/1/11/735/001 20111207
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
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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 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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