Orange Book product · Brand (NDA)

XELJANZ XR

TOFACITINIB CITRATE

Brand (NDA)NDA 208246TE ABRX PFIZER

Feb 23, 2016

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 23, 2016
10 yr 6 mo ago
Patent RE41783 expires
Listed drug substance patent expiration.
Dec 08, 2025
6 mo ago
Patent RE41783*PED expires
Listed listed patent expiration.
Jun 08, 2026
11 d ago
Today
Patent 11253523 expires
Listed method-of-use patent (U-3326) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 11253523 expires
Listed method-of-use patent (U-3327) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 11253523 expires
Listed method-of-use patent (U-3328) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 11253523 expires
Listed method-of-use patent (U-3329) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 9937181 expires
Listed drug product patent expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 11253523*PED expires
Listed listed patent expiration.
Sep 14, 2034
in 8 yr 4 mo
Patent 9937181*PED expires
Listed listed patent expiration.
Sep 14, 2034
in 8 yr 4 mo

Active ingredient

TOFACITINIB CITRATE

Strength

EQ 11MG BASE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Application

NDA 208246

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
RE41783	Dec 08, 2025	6 mo ago	Substance
RE41783*PED	Jun 08, 2026	11 d ago
11253523	Mar 14, 2034	in 7 yr 10 mo	U-3326
11253523	Mar 14, 2034	in 7 yr 10 mo	U-3327
11253523	Mar 14, 2034	in 7 yr 10 mo	U-3328
11253523	Mar 14, 2034	in 7 yr 10 mo	U-3329
9937181	Mar 14, 2034	in 7 yr 10 mo	Product
11253523*PED	Sep 14, 2034	in 8 yr 4 mo
9937181*PED	Sep 14, 2034	in 8 yr 4 mo