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Azilsartan kamedoxomil; chlorthalidone - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for azilsartan kamedoxomil; chlorthalidone?

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.

Azilsartan kamedoxomil; chlorthalidone has ninety-four patent family members in forty 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 / Packagers: see list2
Clinical Trials: see list53
Drug Prices:see low prices
DailyMed Link:azilsartan kamedoxomil; chlorthalidone at DailyMed

Pharmacology for Ingredient: azilsartan kamedoxomil; chlorthalidone

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-002Dec 20, 2011RXYesYes7,157,584► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-001Dec 20, 2011RXYesNo9,066,936► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-001Dec 20, 2011RXYesNo9,169,238► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-002Dec 20, 2011RXYesYes7,572,920► SubscribeY ► Subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-002Dec 20, 2011RXYesYes9,169,238► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: azilsartan kamedoxomil; chlorthalidone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-001Dec 20, 20115,583,141► Subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-002Dec 20, 20115,736,555► Subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-002Dec 20, 20115,583,141► Subscribe
Arbor Pharms Llc
EDARBYCLOR
azilsartan kamedoxomil; chlorthalidone
TABLET;ORAL202331-001Dec 20, 20115,736,555► Subscribe
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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► 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 Ingredient: azilsartan kamedoxomil; chlorthalidone

Country Document Number Estimated Expiration
Spain2388945► Subscribe
China102164918► Subscribe
European Patent Office2310385► Subscribe
CroatiaP20090593► Subscribe
China100503605► 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: AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0120005 00053Estonia► SubscribePRODUCT NAME: IPREZIV - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9281 FINAL 07.12.2011
2012 00013Denmark► Subscribe
2012004Lithuania► SubscribePRODUCT 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
0120004 00052Estonia► SubscribePRODUCT NAME: EDARBI - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9280 FINAL 07.12.2011
90016-3Sweden► SubscribePRODUCT NAME: AZILSARTANMEDOXOMIL OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV, INKLUDERANDE KALIUMSALT; REG. NO/DATE: EU/1/11/735/001 20111207
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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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