Orange Book product · Brand (NDA)

NAFTIN

NAFTIFINE HYDROCHLORIDE

Brand (NDA)NDA 204286TE ABRX LEGACY PHARMA

Jun 27, 2013

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 27, 2013
13 yr 2 mo ago
Today
Patent 10166205 expires
Listed drug product patent expiration.
Jan 31, 2033
in 6 yr 9 mo
Patent 10166206 expires
Listed drug product patent expiration.
Jan 31, 2033
in 6 yr 9 mo
Patent 10695303 expires
Listed drug product patent expiration.
Jan 31, 2033
in 6 yr 9 mo
Patent 10729667 expires
Listed drug product patent expiration.
Jan 31, 2033
in 6 yr 9 mo
Patent 8778365 expires
Listed drug product patent expiration.
Jan 31, 2033
in 6 yr 9 mo
Patent 9161914 expires
Listed method-of-use patent (U-540) expiration.
Jan 31, 2033
in 6 yr 9 mo

Active ingredient

NAFTIFINE HYDROCHLORIDE

Strength

Dosage form

GEL

Route

TOPICAL

TE code

Application

NDA 204286

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
10166205	Jan 31, 2033	in 6 yr 9 mo	Product
10166206	Jan 31, 2033	in 6 yr 9 mo	Product
10695303	Jan 31, 2033	in 6 yr 9 mo	Product
10729667	Jan 31, 2033	in 6 yr 9 mo	Product
8778365	Jan 31, 2033	in 6 yr 9 mo	Product
9161914	Jan 31, 2033	in 6 yr 9 mo	U-540