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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Farmers Insurance
Fish and Richardson
Healthtrust
AstraZeneca
Cipla
McKinsey
Colorcon
QuintilesIMS
Dow

Generated: January 21, 2018

DrugPatentWatch Database Preview

Ambrisentan - Generic Drug Details

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What are the generic drug sources for ambrisentan and what is the scope of ambrisentan patent protection?

Ambrisentan
is the generic ingredient in one branded drug marketed by Gilead and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ambrisentan has one hundred and eleven patent family members in thirty-five countries.

There are nine drug master file entries for ambrisentan. One supplier is listed for this compound.
Pharmacology for ambrisentan

US Patents and Regulatory Information for ambrisentan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 ambrisentan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 ➤ Subscribe ➤ Subscribe
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 ➤ Subscribe ➤ Subscribe
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 ➤ Subscribe ➤ Subscribe
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 ➤ Subscribe ➤ Subscribe
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 ➤ Subscribe ➤ Subscribe
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 ➤ Subscribe ➤ Subscribe
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 ➤ Subscribe ➤ Subscribe
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 ➤ Subscribe ➤ Subscribe
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 ➤ Subscribe ➤ Subscribe
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for ambrisentan

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
6,600,043 Carboxylic acid derivatives, their preparation and use ➤ Subscribe
8,349,843 Carboxylic acid derivatives, their preparation and use ➤ Subscribe
5,772,589 Measurement process for blood gas analysis sensors ➤ Subscribe
7,582,647 Carboxylic acid derivatives, their preparation and use ➤ Subscribe
RE42477 Carboxylic acid derivatives, their preparation and use ➤ Subscribe
9,504,685 Method for treating a pulmonary hypertension condition ➤ Subscribe
5,932,730 Carboxylic acid derivatives, their preparation and use ➤ Subscribe
7,109,205 Carboxylic acid derivatives, their preparation and use ➤ Subscribe
6,197,958 Carboxylic acid derivatives, their preparation and use ➤ Subscribe
5,969,134 Carboxylic acid derivatives, their preparation and use ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for ambrisentan

Supplementary Protection Certificates for ambrisentan

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0160017 00199 Estonia ➤ Subscribe PRODUCT NAME: AMBRISENTAAN;REG NO/DATE: EU/1/08/451 25.11.2015
2016018 Lithuania ➤ Subscribe PRODUCT NAME: AMBRISENTANAS; REGISTRATION NO/DATE: EU/1/08/451 (001-004) 20151120
2008 00037 Denmark ➤ Subscribe
0785926/01 Switzerland ➤ Subscribe FORMER OWNER: ABBVIE DEUTSCHLAND GMBH AND CO. KG, DE
C029/2008 Ireland ➤ Subscribe SPC029/2008: 20091119, EXPIRES: 20201006
081 Luxembourg ➤ Subscribe PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
487 Luxembourg ➤ Subscribe 91487, EXPIRES: 20201007
C/GB08/047 United Kingdom ➤ Subscribe PRODUCT NAME: AMBRISENTAN; REGISTERED: UK EU/1/08/451/001 20080421; UK EU/1/08/451/002 20080421; UK EU/1/08/451/003 20080421; UK EU/1/08/451/004 20080421
0361 Netherlands ➤ Subscribe 300361, 20151007, EXPIRES: 20201006
2016 00024 Denmark ➤ Subscribe PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
Julphar
Mallinckrodt
McKinsey
UBS
US Army
Novartis
Express Scripts

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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