Orange Book product · Brand (NDA)

MITIGARE

COLCHICINE

Brand (NDA)NDA 204820TE ABRX HIKMA INTL PHARMS

Sep 26, 2014

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 26, 2014
11 yr 11 mo ago
Today
Patent 8927607 expires
Listed method-of-use patent (U-1020) expiration.
Aug 22, 2033
in 7 yr 3 mo
Patent 9399036 expires
Listed method-of-use patent (U-1020) expiration.
Aug 22, 2033
in 7 yr 3 mo
Patent 9555029 expires
Listed method-of-use patent (U-1020) expiration.
Aug 22, 2033
in 7 yr 3 mo
Patent 9675613 expires
Listed method-of-use patent (U-1020) expiration.
Aug 22, 2033
in 7 yr 3 mo
Patent 9789108 expires
Listed method-of-use patent (U-1020) expiration.
Aug 22, 2033
in 7 yr 3 mo

Active ingredient

COLCHICINE

Strength

0.6MG

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 204820

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
8927607	Aug 22, 2033	in 7 yr 3 mo	U-1020
9399036	Aug 22, 2033	in 7 yr 3 mo	U-1020
9555029	Aug 22, 2033	in 7 yr 3 mo	U-1020
9675613	Aug 22, 2033	in 7 yr 3 mo	U-1020
9789108	Aug 22, 2033	in 7 yr 3 mo	U-1020