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Generated: November 12, 2018

DrugPatentWatch Database Preview

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 four 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. One supplier is listed for this compound. Additional details are available on the ambrisentan profile page.
Summary for 022081
Tradename:LETAIRIS
Applicant:Gilead
Ingredient:ambrisentan
Patents:4
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 15, 2007TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 2, 2018
Regulatory Exclusivity Use:REVISED INDICATION TO INCLUDE LANGUAGE ABOUT THE BENEFITS OF USING LETAIRIS IN COMBINATION WITH TADALAFIL TO REDUCE THE RISK OF DISEASE PROGRESSION AND HOSPITALIZATION FOR WORSENING PAH AND TO IMPROVE EXERCISE ABILITY, BASED ON THE AMBITION STUDY
Patent:➤ Sign UpPatent Expiration:Dec 11, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL
Patent:➤ Sign UpPatent Expiration:Dec 11, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL

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 ➤ Sign Up ➤ Sign Up
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 ➤ Sign Up ➤ Sign Up
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 ➤ Sign Up ➤ Sign Up
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 ➤ Sign Up ➤ Sign Up
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 ➤ Sign Up ➤ Sign Up
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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