FDA Orange Book · active-ingredient family

Tofacitinib citrate

Tofacitinib citrate: 3 brands, 25 generics; first approved Nov 06, 2012; generic available.

Generic available4 exclusivity periods

Generic status & protection

Generic available — 25 ANDA applications approved.

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

Brands (NDA)

3

Generics (ANDA)

25

Listed patents

8

Next patent expiry

Dec 08, 2025

7 mo ago

Originator applications

Brand (NDA) products

PFIZERNDA 2130822020

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

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

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

Abbreviated applications

Generic (ANDA) products (25)

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

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (4)

M-14New use / labeling-change exclusivity (3 years)
Feb 21, 2028
in 1 yr 8 mo
PEDPediatric exclusivity (adds 6 months)
Aug 21, 2028
in 2 yr 2 mo
M-14New use / labeling-change exclusivity (3 years)
Feb 21, 2028
in 1 yr 8 mo
PEDPediatric exclusivity (adds 6 months)
Aug 21, 2028
in 2 yr 2 mo

Orange Book patent file

Listed patents

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
RE41783	Dec 08, 2025	7 mo ago	Substance
RE41783*PED	Jun 08, 2026	1 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 4 mo
11253523*PED	Sep 14, 2034	in 8 yr 4 mo
10639309*PED	Sep 14, 2034	in 8 yr 4 mo

FDA approval span

Approval history

First approval

Nov 06, 2012

13 yr 11 mo ago

Most recent approval

Jun 09, 2026

1 mo ago

Approvals span 2012–2026 across 28 FDA applications.

Brand (NDA) 311%

Generic (ANDA) 2589%

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.

Related FDA reference tools

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.