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EDARBYCLOR Drug Profile

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Edarbyclor is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug.

This drug has ninety-two patent family members in thirty-eight countries.

The generic ingredient in EDARBYCLOR is azilsartan kamedoxomil; chlorthalidone. 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; chlorthalidone profile page.

Summary for Tradename: EDARBYCLOR

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Formulation / Manufacturing:see details

Clinical Trials for: EDARBYCLOR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-001Dec 20, 2011RXNo7,572,920<disabled>Y <disabled>
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-002Dec 20, 2011RXYes7,157,584<disabled>Y <disabled>
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-001Dec 20, 2011RXNo7,157,584<disabled>Y <disabled>
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Expired Patents for Tradename: EDARBYCLOR

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

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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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: EDARBYCLOR

Country Document Number Estimated Expiration
Russian Federation2369608<disabled in preview>
World Intellectual Property Organization (WIPO)2010013835<disabled in preview>
Japan5283632<disabled in preview>
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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: EDARBYCLOR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
962Luxembourg<disabled>91962, EXPIRES: 20261207
6Finland<disabled>
12/008Ireland<disabled>PRODUCT 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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