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Ambrisentan - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ambrisentan?

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

Ambrisentan has ninety-four patent family members in thirty-two countries.

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

Summary for Generic Name: ambrisentan

Tradenames:1
Patents:5
Applicants:1
NDAs:1
Drug Master File Entries: see list8
Suppliers / Packagers: see list1
Bulk Api Vendors: see list53
Clinical Trials: see list32
Patent Applications: see list1,390
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ambrisentan at DailyMed

Pharmacology for Ingredient: ambrisentan

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 2007RXYesYesRE42462► SubscribeY ► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 2007RXYesNo8,377,933► Subscribe ► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 2007RXYesYes9,474,752► Subscribe ► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 2007RXYesYes8,377,933► Subscribe ► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 2007RXYesYes► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ambrisentan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 20077,109,205► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 20075,703,017► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 20078,349,843► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 20077,601,730► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 20075,932,730► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
7,863,445Carboxylic acid derivatives, their preparation and use► Subscribe
9,504,685Method for treating a pulmonary hypertension condition► Subscribe
7,582,647Carboxylic acid derivatives, their preparation and use► Subscribe
8,349,843Carboxylic acid derivatives, their preparation and use► Subscribe
6,197,958 Carboxylic acid derivatives, their preparation and use► 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: ambrisentan

Country Document Number Estimated Expiration
Hong Kong1066541► Subscribe
New Zealand294849► Subscribe
Japan4512105► Subscribe
Norway308846► Subscribe
China1513844► 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: AMBRISENTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016 00024Denmark► SubscribePRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
2016018Lithuania► SubscribePRODUCT NAME: AMBRISENTANAS; REGISTRATION NO/DATE: EU/1/08/451 (001-004) 20151120
2008 00037Denmark► Subscribe
0813Netherlands► SubscribePRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
C/GB08/047United Kingdom► SubscribePRODUCT 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
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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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