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. Eleven 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

Pharmacology for NDA: 022081

Mechanism of Action	Endothelin Receptor Antagonists

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:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jun 15, 2007	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Dec 11, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL
Patent:	⤷ Sign Up	Patent Expiration:	Dec 11, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL
Patent:	⤷ Sign Up	Patent Expiration:	Oct 14, 2031	Product 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

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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	022081-002	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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