Orange Book product · Brand (NDA)

SOOLANTRA

IVERMECTIN

Brand (NDA)NDA 206255TE ABRX GALDERMA LABS LP

Dec 19, 2014

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 19, 2014
11 yr 8 mo ago
Today
Patent 10206939 expires
Listed method-of-use patent (U-1631) expiration.
Mar 13, 2034
in 7 yr 10 mo
Patent 9089587 expires
Listed method-of-use patent (U-1631) expiration.
Mar 13, 2034
in 7 yr 10 mo
Patent 9233117 expires
Listed method-of-use patent (U-1631) expiration.
Mar 13, 2034
in 7 yr 10 mo
Patent 9233118 expires
Listed method-of-use patent (U-1631) expiration.
Mar 13, 2034
in 7 yr 10 mo
Patent 9782425 expires
Listed method-of-use patent (U-1631) expiration.
Mar 13, 2034
in 7 yr 10 mo

Active ingredient

IVERMECTIN

Strength

Dosage form

CREAM

Route

TOPICAL

TE code

Application

NDA 206255

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
10206939	Mar 13, 2034	in 7 yr 10 mo	U-1631
9089587	Mar 13, 2034	in 7 yr 10 mo	U-1631
9233117	Mar 13, 2034	in 7 yr 10 mo	U-1631
9233118	Mar 13, 2034	in 7 yr 10 mo	U-1631
9782425	Mar 13, 2034	in 7 yr 10 mo	U-1631