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Azilsartan kamedoxomil; chlorthalidone - Generic Drug Details

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Azilsartan kamedoxomil; chlorthalidone is the generic ingredient in one branded drug marketed by Arbor Pharms Llc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are five drug master file entries for azilsartan kamedoxomil; chlorthalidone. Two suppliers are listed for this compound.

Summary for Generic Name: azilsartan kamedoxomil; chlorthalidone

Tradenames:1
Patents:4
Applicants:1
NDAs:1
Drug Master File Entries: see list5
Suppliers / Packaging: see list2
Formulation / Manufacturing:see details

Pharmacology for Ingredient: azilsartan kamedoxomil; chlorthalidone

Clinical Trials for: azilsartan kamedoxomil; chlorthalidone

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;ORAL202331-002Dec 20, 2011RXYes7,572,920<disabled>Y <disabled>
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, 2011RXYes9,066,936<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: azilsartan kamedoxomil; chlorthalidone

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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 Generic Ingredient: azilsartan kamedoxomil; chlorthalidone

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 Ingredient: azilsartan kamedoxomil; chlorthalidone

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: AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

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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