Is there a generic for Tofacitinib citrate?

Yes. The FDA Orange Book lists 26 approved generic (ANDA) applications for Tofacitinib citrate, referencing the brand XELJANZ. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Tofacitinib citrate?

XELJANZ (NDA 213082, PFIZER) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Tofacitinib citrate?

The Orange Book lists 8 patents against Tofacitinib citrate products, with the earliest listed expiry in 2025. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Tofacitinib citrate have FDA marketing exclusivity?

Yes. The Orange Book records 4 marketing-exclusivity periods for Tofacitinib citrate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Tofacitinib citrate are approved?

Tofacitinib citrate is approved in the following dosage forms: solution, tablet, tablet, extended release.

FDA Orange Book · active-ingredient family

Tofacitinib citrate

Tofacitinib citrate: 3 brands, 26 generics; first approved Nov 06, 2012; generic available.

Generic available4 exclusivity periods

Generic status & protection

Generic available: 26 ANDA applications approved.

Earliest patent expiry Dec 08, 2025Latest exclusivity ends Aug 21, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Dec 08, 2025

8 mo ago

Brand (NDA) products

Originator applications

XELJANZRLDRS
PFIZERNDA 2130822020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE/ML SOLUTION ORAL Rx AA
XELJANZ XRRLD
PFIZERNDA 20824620162 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 11MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB
EQ 22MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB
XELJANZRLD
PF PRISM CVNDA 20321420122 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE/ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 11MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 22MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Generic (ANDA) products (26)

Abbreviated applications

TOFACITINIB CITRATE
SCIEGEN PHARMSANDA 2209722026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 11MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB
TOFACITINIB CITRATE
AUSONANDA 2193702026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE/ML SOLUTION ORAL Rx AA
TOFACITINIB CITRATE
SAPTALIS PHARMSANDA 2189002026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE/ML SOLUTION ORAL Rx AA
TOFACITINIB CITRATE
ORIENT PHARMAANDA 2198302026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 11MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB
TOFACITINIB CITRATE
CONCORD BIOTECH LTDANDA 21882120262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
TOFACITINIB CITRATE
YAOPHARMA CO LTDANDA 21555220262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
TOFACITINIB CITRATE
MSNANDA 2172982026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE/ML SOLUTION ORAL Rx AA
TOFACITINIB CITRATE
SUN PHARM INDS INCANDA 2184072026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE/ML SOLUTION ORAL Rx AA
TOFACITINIB CITRATE
APOTEXANDA 2204582026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 11MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB
TOFACITINIB CITRATE
APOTEXANDA 21809620262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
TOFACITINIB CITRATE
AUROBINDO PHARMA LTDANDA 21535620262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
TOFACITINIB CITRATE
BRECKENRIDGEANDA 20963320262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
TOFACITINIB CITRATE
MACLEODS PHARMS LTDANDA 21953020262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
TOFACITINIB CITRATE
MSNANDA 21729920262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
TOFACITINIB CITRATE
SOMERSET THERAPS LLCANDA 22013720262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
TOFACITINIB CITRATE
SPECGX LLCANDA 21939520262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
TOFACITINIB CITRATE
BIOCON PHARMAANDA 2194422025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 11MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB
TOFACITINIB CITRATE
SINOTHERAPEUTICS INCANDA 2160012025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 11MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB
TOFACITINIB CITRATE
AJANTA PHARMA LTDANDA 2195422025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 11MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB
TOFACITINIB CITRATE
DEXCELANDA 2186682024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 11MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB
TOFACITINIB CITRATE
AUROBINDO PHARMA LTDANDA 2184622024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 11MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB
TOFACITINIB CITRATE
HIKMAANDA 2168782023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE/ML SOLUTION ORAL Rx AA
TOFACITINIB CITRATE
MICRO LABSANDA 20973820232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
TOFACITINIB CITRATE
ZYDUS PHARMSANDA 20982920232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
TOFACITINIB CITRATE
ZYDUS PHARMSANDA 21426420212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 11MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB
EQ 22MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB
TOFACITINIB CITRATE
AJANTA PHARMA LTDANDA 2129432021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 11MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE/ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE/ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 11MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE/ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE/ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 11MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 11MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 11MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 11MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 11MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 11MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE/ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 11MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 22MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

M-14New use / labeling-change exclusivity (3 years)
Feb 21, 2028
in 1 yr 7 mo
PEDPediatric exclusivity (adds 6 months)
Aug 21, 2028
in 2 yr 1 mo
M-14New use / labeling-change exclusivity (3 years)
Feb 21, 2028
in 1 yr 7 mo
PEDPediatric exclusivity (adds 6 months)
Aug 21, 2028
in 2 yr 1 mo

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
RE41783	Dec 08, 2025	8 mo ago	Substance
RE41783*PED	Jun 08, 2026	2 mo ago
11253523	Mar 14, 2034	in 7 yr 9 mo	U-3326
9937181	Mar 14, 2034	in 7 yr 9 mo	Product
10639309	Mar 14, 2034	in 7 yr 9 mo	Product
9937181*PED	Sep 14, 2034	in 8 yr 3 mo
11253523*PED	Sep 14, 2034	in 8 yr 3 mo
10639309*PED	Sep 14, 2034	in 8 yr 3 mo

Approval history

FDA approval span

First approval

Nov 06, 2012

13 yr 11 mo ago

Most recent approval

Jun 25, 2026

1 mo ago

Approvals span 2012–2026 across 29 FDA applications.

Brand (NDA) 310%

Generic (ANDA) 2690%

Tofacitinib citrate: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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