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EDARBI Drug Profile

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Which patents cover Edarbi, and what substitute generic drugs are available?

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 sixty-nine patent family members in thirty-two 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 list27
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 2011RXYesNo7,572,920► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 2011RXYesYes7,572,920► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 2011RXYesNo9,066,936► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 2011RXYesNo7,157,584► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 2011RXYesYes7,157,584► 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, 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 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
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: EDARBI

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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