Orange Book product · Brand (NDA)

GLOPERBA

COLCHICINE

Brand (NDA)NDA 210942RX SCILEX PHARMS

Jan 30, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 30, 2019
7 yr 6 mo ago
Today
Patent 10383820 expires
Listed drug product patent expiration.
Nov 22, 2036
in 10 yr 7 mo
Patent 10383821 expires
Listed drug product patent expiration.
Nov 22, 2036
in 10 yr 7 mo
Patent 12274751 expires
Listed method-of-use patent (U-2814) expiration.
Nov 22, 2036
in 10 yr 7 mo
Patent 12514819 expires
Listed method-of-use patent (U-2814) expiration.
Nov 22, 2036
in 10 yr 7 mo
Patent 9907751 expires
Listed drug product patent expiration.
Nov 22, 2036
in 10 yr 7 mo
Patent 10226423 expires
Listed drug product patent expiration.
Dec 20, 2037
in 11 yr 8 mo

Active ingredient

COLCHICINE

Strength

0.6MG/5ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 210942

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
10383820	Nov 22, 2036	in 10 yr 7 mo	ProductU-2814
10383821	Nov 22, 2036	in 10 yr 7 mo	Product
12274751	Nov 22, 2036	in 10 yr 7 mo	U-2814
12514819	Nov 22, 2036	in 10 yr 7 mo	U-2814
9907751	Nov 22, 2036	in 10 yr 7 mo	Product
10226423	Dec 20, 2037	in 11 yr 8 mo	Product