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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;ORAL200796-001Feb 25, 20115,958,961<disabled>
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 20115,583,141<disabled>
Arbor Pharms Llc
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 20115,736,555<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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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
Hong Kong1115118<disabled in preview>
TaiwanI336702<disabled in preview>
Denmark2119715<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: EDARBI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0120005 00053Estonia<disabled>PRODUCT NAME: IPREZIV - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9281 FINAL 07.12.2011
00525Netherlands<disabled>PRODUCT NAME: AZILSARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCHE AANVAARDBAAR ZOUT, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/11/734/001-011EU/1/11/735/001-011 2011071207
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