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EDARBI Drug Profile

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Edarbi is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from two suppliers. 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
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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;ORAL200796-001Feb 25, 20115,736,555► subscribe
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 20115,736,555► 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
TaiwanI336702► subscribe
Norway2012017► subscribe
Portugal1857457► 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
1718641/01Switzerland► subscribePRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
90016-3Sweden► subscribePRODUCT NAME: AZILSARTANMEDOXOMIL OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV, INKLUDERANDE KALIUMSALT; REG. NO/DATE: EU/1/11/735/001 20111207
6Finland► subscribe
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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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