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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-eight patent family members in thirty-one 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

Pharmacology for Tradename: EDARBI

Clinical Trials for: EDARBI

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 2011RXNo7,572,920<disabled>Y <disabled>
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 2011RXYes7,157,584<disabled>Y <disabled>
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 2011RXNo<disabled><disabled>
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Expired Patents for Tradename: EDARBI

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 20115,583,141<disabled>
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 20115,958,961<disabled>
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 20115,583,141<disabled>
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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<disabled in preview>
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International Patent Family for Tradename: EDARBI

Country Document Number Estimated Expiration
Portugal1857457<disabled in preview>
China1946717<disabled in preview>
Portugal1718641<disabled in preview>
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Supplementary Protection Certificates for Tradename: EDARBI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012004,C1718641Lithuania<disabled>PRODUCT 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<disabled>PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
6Finland<disabled>
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