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Last Updated: August 6, 2020

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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.

US ANDA 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
Medical University of South CarolinaPhase 4
Ochsner Health SystemPhase 4
National Heart, Lung, and Blood Institute (NHLBI)Phase 1

See all LETAIRIS clinical trials

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
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 022081-002 Jun 15, 2007 AB RX Yes Yes   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 022081-002 Jun 15, 2007   Start Trial   Start Trial
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 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
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 93081 Luxembourg   Start Trial PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
2101777 CA 2016 00024 Denmark   Start Trial PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
0785926 91487 Luxembourg   Start Trial 91487, EXPIRES: 20201007
2101777 300813 Netherlands   Start Trial PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
0785926 300361 Netherlands   Start Trial 300361, 20151007, EXPIRES: 20201006
2101777 2016C/032 Belgium   Start Trial PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Dow
Moodys
Colorcon

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