Orange Book product · Brand (NDA)

ZIPSOR

DICLOFENAC POTASSIUM

Brand (NDA)NDA 022202TE ABRX ASSERTIO SPECLTY

Jun 16, 2009

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 16, 2009
17 yr 3 mo ago
Today
Patent 7662858 expires
Listed method-of-use patent (U-1035) expiration.
Feb 24, 2029
in 2 yr 9 mo
Patent 7884095 expires
Listed method-of-use patent (U-1111) expiration.
Feb 24, 2029
in 2 yr 9 mo
Patent 7939518 expires
Listed method-of-use patent (U-980) expiration.
Feb 24, 2029
in 2 yr 9 mo
Patent 8110606 expires
Listed method-of-use patent (U-980) expiration.
Feb 24, 2029
in 2 yr 9 mo
Patent 8623920 expires
Listed method-of-use patent (U-1482) expiration.
Feb 24, 2029
in 2 yr 9 mo
Patent 9561200 expires
Listed method-of-use patent (U-1482) expiration.
Feb 24, 2029
in 2 yr 9 mo

Active ingredient

DICLOFENAC POTASSIUM

Strength

25MG

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 022202

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
7662858	Feb 24, 2029	in 2 yr 9 mo	U-1035
7884095	Feb 24, 2029	in 2 yr 9 mo	U-1111
7939518	Feb 24, 2029	in 2 yr 9 mo	U-980
8110606	Feb 24, 2029	in 2 yr 9 mo	U-980
8623920	Feb 24, 2029	in 2 yr 9 mo	U-1482
9561200	Feb 24, 2029	in 2 yr 9 mo	U-1482