Orange Book product · Brand (NDA)

LETAIRIS

AMBRISENTAN

Brand (NDA)NDA 022081TE ABRX GILEAD

Jun 15, 2007

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 15, 2007
19 yr 3 mo ago
Today
Patent 8377933 expires
Listed method-of-use patent (U-1754) expiration.
Dec 11, 2027
in 1 yr 6 mo
Patent 9474752 expires
Listed method-of-use patent (U-1754) expiration.
Dec 11, 2027
in 1 yr 6 mo
Patent 9549926 expires
Listed method-of-use patent (U-1965) expiration.
Oct 14, 2031
in 5 yr 5 mo

Active ingredient

AMBRISENTAN

Strength

5MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 022081

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8377933	Dec 11, 2027	in 1 yr 6 mo	U-1754
9474752	Dec 11, 2027	in 1 yr 6 mo	U-1754
9549926	Oct 14, 2031	in 5 yr 5 mo	U-1965