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Last Updated: April 15, 2021

DrugPatentWatch Database Preview

LETAIRIS Drug 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.

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

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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 NDA Submissiondate
LETAIRIS TABLET;ORAL ambrisentan 022081 2015-02-09

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 AB RX Yes No   Start Trial   Start Trial   Start Trial
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 AB RX Yes No   Start Trial   Start Trial   Start 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 022081-001 Jun 15, 2007   Start Trial   Start Trial
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007   Start Trial   Start Trial
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for LETAIRIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2101777 C20160017 00199 Estonia   Start Trial PRODUCT NAME: AMBRISENTAAN;REG NO/DATE: EU/1/08/451 25.11.2015
0785926 CA 2008 00037 Denmark   Start Trial
2101777 93081 Luxembourg   Start Trial PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
McKinsey
Medtronic
Dow
Moodys
Colorcon

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