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Serving leading biopharmaceutical companies globally:

Fuji
Novartis
Farmers Insurance
Express Scripts
Colorcon
Cerilliant
McKinsey
McKesson
Teva
Baxter

Generated: January 20, 2018

DrugPatentWatch Database Preview

LETAIRIS Drug Profile

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When do Letairis patents expire, and what generic alternatives are available?

Letairis is a drug marketed by Gilead and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in LETAIRIS is ambrisentan. There are nine 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 LETAIRIS
Drug patent expirations by year for LETAIRIS
Pharmacology for LETAIRIS

US Patents and Regulatory Information for LETAIRIS

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 022081-001 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 022081-001 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 022081-002 Jun 15, 2007 RX Yes Yes ➤ 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 LETAIRIS

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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Paragraph IV (Patent) Challenges for LETAIRIS
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 5 mg and 10 mg ➤ Subscribe 2/9/2015

Non-Orange Book US Patents for 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
5,969,134 Carboxylic acid derivatives, their preparation and use ➤ Subscribe
7,601,730 Carboxylic acid derivatives, their preparation and use ➤ Subscribe
9,504,685 Method for treating a pulmonary hypertension condition ➤ Subscribe
7,109,205 Carboxylic acid derivatives, their preparation and use ➤ Subscribe
RE42477 Carboxylic acid derivatives, their preparation and use ➤ Subscribe
7,863,445 Carboxylic acid derivatives, their preparation and use ➤ Subscribe
8,349,843 Carboxylic acid derivatives, their preparation and use ➤ Subscribe
6,197,958 Carboxylic acid derivatives, their preparation and use ➤ Subscribe
5,932,730 Carboxylic acid derivatives, their preparation and use ➤ Subscribe
5,772,589 Measurement process for blood gas analysis sensors ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for LETAIRIS

Supplementary Protection Certificates for LETAIRIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
081 Luxembourg ➤ Subscribe PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
0813 Netherlands ➤ Subscribe PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
0361 Netherlands ➤ Subscribe 300361, 20151007, EXPIRES: 20201006
0160017 00199 Estonia ➤ Subscribe PRODUCT NAME: AMBRISENTAAN;REG NO/DATE: EU/1/08/451 25.11.2015
0785926/01 Switzerland ➤ Subscribe FORMER OWNER: ABBVIE DEUTSCHLAND GMBH AND CO. KG, DE
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
C0041 France ➤ Subscribe PRODUCT NAME: AMBRISENTAN; REGISTRATION NO/DATE: EU/1/08/451/001-004 20080421
2016 00024 Denmark ➤ Subscribe PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
C029/2008 Ireland ➤ Subscribe SPC029/2008: 20091119, EXPIRES: 20201006
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Daiichi Sankyo
Express Scripts
Cantor Fitzgerald
Chinese Patent Office
Colorcon
Deloitte
Cerilliant
Baxter

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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