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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
UBS
Citi
US Department of Justice
Covington
Daiichi Sankyo
Chubb
Novartis
Deloitte
Medtronic

Generated: February 23, 2018

DrugPatentWatch Database Preview

EDARBI Drug Profile

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When do Edarbi patents expire, and when can generic versions of Edarbi launch?

Edarbi is a drug marketed by Arbor Pharms Llc and is included in one NDA. There are three patents protecting this drug.

This drug has eighty patent family members in thirty-four countries.

The generic ingredient in EDARBI is azilsartan kamedoxomil. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the azilsartan kamedoxomil profile page.
Summary for EDARBI
Drug patent expirations by year for EDARBI
Pharmacology for EDARBI

US Patents and Regulatory Information for EDARBI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Arbor Pharms Llc EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Arbor Pharms Llc EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-002 Feb 25, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Arbor Pharms Llc EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Arbor Pharms Llc EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Arbor Pharms Llc EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-002 Feb 25, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Arbor Pharms Llc EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-002 Feb 25, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for EDARBI

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Arbor Pharms Llc EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011 ➤ Sign Up ➤ Sign Up
Arbor Pharms Llc EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-002 Feb 25, 2011 ➤ Sign Up ➤ Sign Up
Arbor Pharms Llc EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011 ➤ Sign Up ➤ Sign Up
Arbor Pharms Llc EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-002 Feb 25, 2011 ➤ Sign Up ➤ Sign Up
Arbor Pharms Llc EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-001 Feb 25, 2011 ➤ Sign Up ➤ Sign Up
Arbor Pharms Llc EDARBI azilsartan kamedoxomil TABLET;ORAL 200796-002 Feb 25, 2011 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
7,875,637 Benzimidazole derivative and use as a II receptor antagonist ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for EDARBI

Supplementary Protection Certificates for EDARBI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0120004 00052 Estonia ➤ Sign Up PRODUCT NAME: EDARBI - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9280 FINAL 07.12.2011
2012 00013 Denmark ➤ Sign Up
90016-3 Sweden ➤ Sign Up PRODUCT NAME: AZILSARTANMEDOXOMIL OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV, INKLUDERANDE KALIUMSALT; REG. NO/DATE: EU/1/11/735/001 20111207
00525 Netherlands ➤ Sign Up 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
C/GB12/028 United Kingdom ➤ Sign Up PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
2012004,C1718641 Lithuania ➤ Sign Up PRODUCT 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
6 Finland ➤ Sign Up
0802 Netherlands ➤ Sign Up PRODUCT NAME: AZILSARTAN MEDOXOMIL EN CHLOORTALIDON; NATIONAL REGISTRATION NO/DATE: RVG116387 20151125; FIRST REGISTRATION: CH 6314502 20141028
12/008 Ireland ➤ Sign Up 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
962 Luxembourg ➤ Sign Up 91962, EXPIRES: 20261207
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
UBS
Teva
Cantor Fitzgerald
Chinese Patent Office
Argus Health
Dow
Express Scripts
QuintilesIMS

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