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LETAIRIS Drug Profile

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Letairis is a drug marketed by Gilead and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eight patent family members in thirty countries.

The generic ingredient in LETAIRIS is ambrisentan. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ambrisentan profile page.

Summary for Tradename: LETAIRIS

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: LETAIRIS

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 2007RXNo5,840,722► subscribe ► subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 2007RXNoRE42462► subscribeY ► subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 2007RXNo8,377,933► subscribe ► subscribe
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Expired Patents for Tradename: LETAIRIS

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 20075,840,722► subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 20077,601,730► subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 20075,703,017► subscribe
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Paragraph IV activity for: LETAIRIS

Drugname Dosage Strength RLD Submissiondate
ambrisentanTablets5 mg and 10 mgLetairis2/9/2015

Non-Orange Book Patents for Tradename: LETAIRIS

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
7,582,647Carboxylic acid derivatives, their preparation and use► subscribe
7,863,445Carboxylic acid derivatives, their preparation and use► subscribe
5,772,589 Measurement process for blood gas analysis sensors► 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 Tradename: LETAIRIS

Country Document Number Estimated Expiration
Norway2008015► subscribe
World Intellectual Property Organization (WIPO)2008073928► subscribe
China1160396► 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: LETAIRIS

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
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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