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Last Updated: May 20, 2022

LETAIRIS Drug Patent Profile


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

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

This drug has fifty patent family members in twenty-six countries.

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

Drug patent expirations by year for LETAIRIS
Drug Prices for LETAIRIS

See drug prices for LETAIRIS

Recent Clinical Trials for LETAIRIS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Medical University of South CarolinaPhase 4
Ochsner Health SystemPhase 4
Augusta UniversityPhase 1

See all LETAIRIS clinical trials

Pharmacology for LETAIRIS
Paragraph IV (Patent) Challenges for LETAIRIS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LETAIRIS Tablets ambrisentan 5 mg and 10 mg 022081 1 2015-02-09

US Patents and Regulatory Information for LETAIRIS

LETAIRIS is protected by three US patents.

Patents protecting LETAIRIS

Method for treating a pulmonary hypertension condition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL

Method for treating a pulmonary hypertension condition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL

Compositions and methods of treating pulmonary hypertension
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL, WHEREIN THE WEIGHT RATIO OF AMBRISENTAN TO TADALAFIL IS ABOUT 1:2 TO ABOUT 1:3

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

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 See Plans and Pricing See Plans and Pricing
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 See Plans and Pricing See Plans and Pricing
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 See Plans and Pricing See Plans and Pricing
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 See Plans and Pricing See Plans and Pricing
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for LETAIRIS

When does loss-of-exclusivity occur for LETAIRIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 07333115
Estimated Expiration: See Plans and Pricing

Canada

Patent: 69536
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 16597
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 01777
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 01777
Estimated Expiration: See Plans and Pricing

Patent: 52193
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 18393
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 25355
Estimated Expiration: See Plans and Pricing

Patent: 600027
Estimated Expiration: See Plans and Pricing

Japan

Patent: 10512414
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 081
Estimated Expiration: See Plans and Pricing

Poland

Patent: 01777
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 01777
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 01777
Estimated Expiration: See Plans and Pricing

Spain

Patent: 44724
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LETAIRIS around the world.

Country Patent Number Title Estimated Expiration
China 1066141 See Plans and Pricing
Japan 5806320 See Plans and Pricing
Austria 204471 See Plans and Pricing
Australia 2011315891 Compositions and methods of treating pulmonary hypertension See Plans and Pricing
Spain 2162942 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LETAIRIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0785926 C00785926/01 Switzerland See Plans and Pricing FORMER OWNER: ABBVIE DEUTSCHLAND GMBH AND CO. KG, DE
2101777 2016C/032 Belgium See Plans and Pricing PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125
0785926 SPC/GB08/047 United Kingdom See Plans and Pricing 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
2101777 93081 Luxembourg See Plans and Pricing PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
2101777 C20160017 00199 Estonia See Plans and Pricing PRODUCT NAME: AMBRISENTAAN;REG NO/DATE: EU/1/08/451 25.11.2015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Moodys
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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 verification 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.