Tofacitinib (Xeljanz)

Generics already compete: 22 makers on the market. 40 A-rated products from 22 makers substitute at the counter.

Xeljanz was first approved by the FDA on 11/06/2012 under NDA 203214; the application holder is Pf Prism Cv.

The latest NADAC for TOFACITINIB 5 MG TABLET is $0.56 per unit (as of 10/28/2026).

Holder Pf Prism CvApplication NDA 203214Approved 11/06/2012

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Data as of 10/31/2026

Market protection1 yr 9 moXeljanz exclusivity ends 08/21/2028 Generics22 makers2 staged, awaiting entry FDA shortageClearNot listedCurrent FDA list NADAC$0.56 / unitAs of 10/28/2026

01Patents and exclusivity

When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.

660days until Xeljanz exclusivity ends

ExclusivityPatent onlyOpen to generics

Today

Approved11/06/2012

Last patent06/08/2026

Exclusivity ends08/21/2028

201320162019202220252028

Latest patent: 06/08/2026Xeljanz
Exclusivity: 08/21/2028Xeljanz
Later patents, other products: Xeljanz XR 09/14/2034

02Competition

Generics: 22 generic makers
Staged generics: 2 passed FDA review, awaiting market entry
First generic approved: 06/01/2021

Every listingEach listing and maker behind the generics count.

Price erosionHow NADAC moves as generics enter.

PrescribersWho prescribes it, from Medicare data.

Available in the full Tofacitinib profile.See what is included

03Supply and price

FDA drug shortage: ClearNot on the current shortage list
NADAC: $0.56 per unitTOFACITINIB 5 MG TABLET, as of 10/28/2026

04Product

Application holder: Pf Prism Cv
Application: NDA 203214
First approved: 11/06/2012
Dosage forms: solution; tablet; tablet, extended release
Routes: oral
Other brand names: Xeljanz XR

Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.