Orange Book product · Brand (NDA)

ELYXYB

CELECOXIB

Brand (NDA)NDA 212157RX SCILEX PHARMS

May 05, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 05, 2020
6 yr 3 mo ago
Today
Patent 10376527 expires
Listed drug product patent expiration.
May 27, 2036
in 10 yr 1 mo
Patent 10722456 expires
Listed drug product patent expiration.
May 27, 2036
in 10 yr 1 mo
Patent 10799517 expires
Listed drug product patent expiration.
May 27, 2036
in 10 yr 1 mo
Patent 9572819 expires
Listed drug product patent expiration.
May 27, 2036
in 10 yr 1 mo
Patent 9795620 expires
Listed drug product patent expiration.
May 27, 2036
in 10 yr 1 mo
Patent 9949990 expires
Listed drug product patent expiration.
May 27, 2036
in 10 yr 1 mo

Active ingredient

CELECOXIB

Strength

25MG/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 212157

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
10376527	May 27, 2036	in 10 yr 1 mo	ProductU-2718
10722456	May 27, 2036	in 10 yr 1 mo	ProductU-2718
10799517	May 27, 2036	in 10 yr 1 mo	ProductU-2718
9572819	May 27, 2036	in 10 yr 1 mo	ProductU-2718
9795620	May 27, 2036	in 10 yr 1 mo	ProductU-2718
9949990	May 27, 2036	in 10 yr 1 mo	ProductU-2718