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Last Updated: March 28, 2024

LETAIRIS Drug Patent Profile


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Which patents cover Letairis, and what generic alternatives are available?

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. Ten suppliers are listed for this compound. Additional details are available on the ambrisentan profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Letairis

A generic version of LETAIRIS was approved as ambrisentan by MYLAN on March 28th, 2019.

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Drug patent expirations by year for LETAIRIS
Drug Prices for LETAIRIS

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Recent Clinical Trials for LETAIRIS

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

SponsorPhase
Ochsner Health SystemPhase 4
Medical University of South CarolinaPhase 4
Gilead SciencesPhase 1

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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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL

Method for treating a pulmonary hypertension condition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL

Compositions and methods of treating pulmonary hypertension
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 ⤷  Try a Trial ⤷  Try a Trial
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for LETAIRIS

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
GlaxoSmithKline (Ireland) Limited Volibris ambrisentan EMEA/H/C/000839
Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1).  Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.Volibris is indicated for treatment of PAH in adolescents and children (aged 8 to less than 18 years) of WHO Functional Class (FC) II to III including use in combination treatment. Efficacy has been shown in IPAH, familial, corrected congenital and in PAH associated with connective tissue disease (see section 5.1).
Authorised no no no 2008-04-20
Mylan S.A.S Ambrisentan Mylan ambrisentan EMEA/H/C/004985
Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.
Authorised yes no no 2019-06-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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: ⤷  Try a Trial

Canada

Patent: 69536
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 16597
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 01777
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 01777
Estimated Expiration: ⤷  Try a Trial

Patent: 52193
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 18393
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 25355
Estimated Expiration: ⤷  Try a Trial

Patent: 600027
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 10512414
Estimated Expiration: ⤷  Try a Trial

Luxembourg

Patent: 081
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 01777
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 01777
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 01777
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 44724
Estimated Expiration: ⤷  Try a Trial

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
Germany 19533023 Neue Carbonsäurederivate, ihre Herstellung und Verwendung ⤷  Try a Trial
Hong Kong 1218393 用於治療肺高壓的複合物 (COMPOSITION FOR TREATING A PULMONARY HYPERTENSION) ⤷  Try a Trial
Portugal 695295 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LETAIRIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0785926 SPC/GB08/047 United Kingdom ⤷  Try a Trial 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
0785926 300361 Netherlands ⤷  Try a Trial 300361, 20151007, EXPIRES: 20201006
0785926 91487 Luxembourg ⤷  Try a Trial 91487, EXPIRES: 20201007
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.