Orange Book product · Brand (NDA)

XELJANZ

TOFACITINIB CITRATE

Brand (NDA)NDA 213082TE AARX PFIZER

Sep 25, 2020

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 25, 2020
5 yr 10 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
Exclusivity ends · M-14
New use / labeling-change exclusivity (3 years)
Feb 21, 2028
in 1 yr 8 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Aug 21, 2028
in 2 yr 2 mo

Active ingredient

TOFACITINIB CITRATE

Strength

EQ 1MG BASE/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Application

NDA 213082

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
RE41783	Dec 08, 2025	6 mo ago	Substance
RE41783*PED	Jun 08, 2026	11 d ago