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Serving leading biopharmaceutical companies globally:

Covington
UBS
McKesson
Queensland Health
Harvard Business School
Express Scripts
AstraZeneca
Cerilliant
Boehringer Ingelheim
US Department of Justice

Generated: December 17, 2017

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AZILSARTAN KAMEDOXOMIL - Generic Drug Details

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What are the generic sources for azilsartan kamedoxomil and what is the scope of azilsartan kamedoxomil freedom to operate?

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

Azilsartan kamedoxomil has eighty patent family members in thirty-four countries and fifteen supplementary protection certificates in twelve countries.

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

Pharmacology for AZILSARTAN KAMEDOXOMIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Arbor Pharms LlcEDARBYCLORazilsartan kamedoxomil; chlorthalidoneTABLET;ORAL202331-001Dec 20, 2011RXYesNo► Subscribe► SubscribeY► Subscribe
Arbor Pharms LlcEDARBYCLORazilsartan kamedoxomil; chlorthalidoneTABLET;ORAL202331-002Dec 20, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
Arbor Pharms LlcEDARBIazilsartan kamedoxomilTABLET;ORAL200796-002Feb 25, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
Arbor Pharms LlcEDARBYCLORazilsartan kamedoxomil; chlorthalidoneTABLET;ORAL202331-001Dec 20, 2011RXYesNo► Subscribe► SubscribeY► Subscribe
Arbor Pharms LlcEDARBIazilsartan kamedoxomilTABLET;ORAL200796-002Feb 25, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
Arbor Pharms LlcEDARBIazilsartan kamedoxomilTABLET;ORAL200796-001Feb 25, 2011RXYesNo► Subscribe► SubscribeY► Subscribe
Arbor Pharms LlcEDARBIazilsartan kamedoxomilTABLET;ORAL200796-002Feb 25, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
Arbor Pharms LlcEDARBYCLORazilsartan kamedoxomil; chlorthalidoneTABLET;ORAL202331-002Dec 20, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
Arbor Pharms LlcEDARBYCLORazilsartan kamedoxomil; chlorthalidoneTABLET;ORAL202331-001Dec 20, 2011RXYesNo► Subscribe► SubscribeY► Subscribe
Arbor Pharms LlcEDARBYCLORazilsartan kamedoxomil; chlorthalidoneTABLET;ORAL202331-002Dec 20, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: azilsartan kamedoxomil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Arbor Pharms LlcEDARBIazilsartan kamedoxomilTABLET;ORAL200796-002Feb 25, 2011► Subscribe► Subscribe
Arbor Pharms LlcEDARBIazilsartan kamedoxomilTABLET;ORAL200796-001Feb 25, 2011► Subscribe► Subscribe
Arbor Pharms LlcEDARBIazilsartan kamedoxomilTABLET;ORAL200796-002Feb 25, 2011► Subscribe► Subscribe
Arbor Pharms LlcEDARBIazilsartan kamedoxomilTABLET;ORAL200796-002Feb 25, 2011► Subscribe► Subscribe
Arbor Pharms LlcEDARBIazilsartan kamedoxomilTABLET;ORAL200796-001Feb 25, 2011► Subscribe► Subscribe
Arbor Pharms LlcEDARBIazilsartan kamedoxomilTABLET;ORAL200796-001Feb 25, 2011► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: azilsartan kamedoxomil

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

Country Document Number Estimated Expiration
Japan2010522692► Subscribe
Netherlands300802► Subscribe
Norway332344► Subscribe
Luxembourg91962► Subscribe
CroatiaP20090593► Subscribe
Spain2293552► Subscribe
Malaysia142807► Subscribe
Israel201188► Subscribe
European Patent Office2119715► Subscribe
Russian Federation2369608► 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1 5004-2012Slovakia► SubscribePRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/735/011 20111207
1718641/01Switzerland► SubscribePRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
0120005 00053Estonia► SubscribePRODUCT NAME: IPREZIV - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9281 FINAL 07.12.2011
C0034France► SubscribePRODUCT NAME: AZILSARTAN MEDOXOMIL ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/735/001 20111207
0120004 00052Estonia► SubscribePRODUCT NAME: EDARBI - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9280 FINAL 07.12.2011
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
962Luxembourg► Subscribe91962, EXPIRES: 20261207
6Finland► Subscribe
2012004,C1718641Lithuania► 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
12/008Ireland► SubscribePRODUCT 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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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Boehringer Ingelheim
Cantor Fitzgerald
Accenture
Chinese Patent Office
Mallinckrodt
McKesson
Moodys
Cerilliant
AstraZeneca

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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