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Last Updated: November 18, 2019

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Details for New Drug Application (NDA): 022081

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NDA 022081 describes LETAIRIS, which is a drug marketed by Gilead and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LETAIRIS profile page.

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.
Summary for 022081
Tradename:LETAIRIS
Applicant:Gilead
Ingredient:ambrisentan
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 022081
Suppliers and Packaging for NDA: 022081
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LETAIRIS ambrisentan TABLET;ORAL 022081 NDA Gilead Sciences, Inc 61958-0801 61958-0801-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-1)
LETAIRIS ambrisentan TABLET;ORAL 022081 NDA Gilead Sciences, Inc 61958-0801 61958-0801-2 3 BLISTER PACK in 1 CARTON (61958-0801-2) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 022081
Tradename Dosage Ingredient NDA Submissiondate
LETAIRIS TABLET;ORAL ambrisentan 022081 2015-02-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 15, 2007TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Dec 11, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL
Patent:  Start TrialPatent Expiration:Dec 11, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL
Patent:  Start TrialPatent Expiration:Oct 14, 2031Product Flag?Substance Flag?Delist Request?
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

Expired US Patents for NDA 022081

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 022081-001 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

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