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Merck
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Federal Trade Commission
Queensland Health
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Novartis
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Baxter
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Generated: October 17, 2017

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 eight 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 NDA: 022081

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4
Therapeutic Class:Respiratory Tract Agents
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

Summary 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:► SubscribePatent Expiration:Dec 11, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL
Patent:► SubscribePatent Expiration:Dec 11, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL

Expired Orange Book Patents for NDA: 022081

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 2007► Subscribe► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 2007► Subscribe► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 2007► Subscribe► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 2007► Subscribe► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 2007► Subscribe► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 2007► Subscribe► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 2007► Subscribe► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-002Jun 15, 2007► Subscribe► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 2007► Subscribe► Subscribe
Gilead
LETAIRIS
ambrisentan
TABLET;ORAL022081-001Jun 15, 2007► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Argus Health
Harvard Business School
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Julphar

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