Viewing data from:

XELJANZ XR

NDA

TOFACITINIB CITRATE | N208246 | PFIZER INC

2 strengths4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Expired (1)Active (3)TodayPED (+6 mo)

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

Jun. 8, 2026

Sep. 14, 2034

Sep. 14, 2034

Sep. 14, 2034

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

10 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Pfizer Inc. et al v. Apotex Inc. 1:2025cv00775 1 patentANDA 220458tofacitinib citrate	D. Del.	2025-06-23	Terminated 2025-10-20	—
Pfizer Inc. et al v. Orient Pharma Co., Ltd. 1:2025cv00743 3 patentsANDA 219830tofacitinib citrate	D. Del.	2025-06-16	Terminated 2025-09-05	—
Pfizer Inc. et al v. Alkem Laboratories Limited 1:2025cv00565 4 patentsANDA 220395tofacitinib citrate	D. Del.	2025-05-07	Terminated 2025-06-20	—
Pfizer Inc. et al v. Sinotherapeutics Inc. 1:2022cv01484	D. Del.	2022-11-11	Terminated 2024-10-03	—
Pfizer Inc. et al v. Teva Pharmaceuticals USA, Inc. 1:2022cv00192	D. Del.	2022-02-11	Terminated 2022-04-26	—
Pfizer Inc. et al v. Sinotherapeutics Inc. 1:2021cv01427 1 patentANDA 216001tofacitinib citrate	D. Del.	2021-10-06	Terminated 2024-10-03	—
Pfizer Inc. et al v. Zydus Pharmaceuticals (USA) Inc. et al 1:2021cv00214 3 patentsANDA 214264tofacitinib citrate	D. Del.	2021-02-16	Terminated 2021-04-16	—
Pfizer Inc. et al. v. Teva Pharmaceuticals USA, Inc. 1:2018cv01940 1 patentANDA 209813tofacitinib citrate	D. Del.	2018-12-07	Terminated 2021-09-08	—
Pfizer Inc. v. Sun Pharmaceutical Industries Limited et al 1:2018cv01529 1 patentANDA 209790tofacitinib citrate	D. Del.	2018-10-03	Terminated 2019-04-11	—
Pfizer Inc. et al v. Sun Pharmaceutical Industries Limited et al 1:2017cv01597 1 patentANDA 209790tofacitinib citrate	D. Del.	2017-11-07	Terminated 2019-03-07	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

68 trials from ClinicalTrials.gov — 3 recruiting, 54 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Advanced Therapeutics in Rheumatoid Arthritis (RA)NCT03976245	Phase 4	Recruiting	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	144	2020-03-01 → 2025-03
Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response NCT03414502	Phase 3	Recruiting	University of Nebraska	400	2007-12-10 → 2029-03
Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction NCT03681275	Phase 2	Recruiting	Stanford University	70	2019-09-03 → 2026-11-30
Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis NCT02831855	Phase 4	Completed	Pfizer	694	2016-09-01 → 2018-12-17
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus NCT02535689	Phase 1	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	34	2015-08-28 → 2018-04-26
Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)NCT01164579	Phase 2	Completed	Pfizer	109	2010-10 → 2013-11
Tofacitinib Ointment For Chronic Plaque Psoriasis NCT01831466	Phase 2	Completed	Pfizer	476	2013-05 → 2014-09
Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis NCT03486457	Phase 3	Completed	Pfizer	204	2018-08-10 → 2021-04-28
Mesothelin-Targeted Immunotoxin LMB-100 in Combination With Tofacitinib in Persons With Previously Treated Pancreatic Adenocarcinoma, Cholangiocarcinoma and Other Mesothelin Expressing Solid Tumors NCT04034238	Phase 1	Completed	National Cancer Institute (NCI)	19	2019-08-29 → 2021-11-19
Open-label Trial of Tofacitinib in Cutaneous Sarcoidosis and Granuloma Annulare NCT03910543	Phase 1	Completed	Yale University	15	2019-04-11 → 2021-06-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$207.85

per ea

Lowest NADAC/Unit

$207.85

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00069050130XELJANZ XR 11 MG TABLET	$207.85	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$4309.87

Highest Price

$5888.71

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00069-0502-30XELJANZ 22MG 24HR TAB,XR	$5888.71	FSS	Pfizer Inc.	06/30/2029
00069-0502-30XELJANZ 22MG 24HR TAB,XR	$4334.13	Big4	Pfizer Inc.	06/30/2029
00069-0501-30XELJANZ 1MG TAB, XR	$5888.71	FSS	Pfizer Inc.	06/30/2029
00069-0501-30XELJANZ 1MG TAB, XR	$4309.87	Big4	Pfizer Inc.	06/30/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Xeljanz XR (2024)

Total Spending

$589.8M

Total Claims

94,342

Beneficiaries

12,581

Avg Cost/Unit

$190.71

Spending Trend

$474.0M(2019)→$575.3M(2020)→$625.7M(2021)→$591.1M(2022)→$585.8M(2023)→$589.8M(2024)

YoY Change:-0.5%

5yr CAGR:+4.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain30 active DMFs1 inactive

29 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDTOFACITINIB CITRATE [ROUTE CODE - TT"]

DMF 277212013

ALIVUS LIFE SCIENCES LTDTOFACITINIB CITRATE

DMF 290022015

ZYDUS LIFESCIENCES LTDTOFACITINIB CITRATE

DMF 305312016

SHANDONG ANXIN PHARMACEUTICAL CO LTDTOFACITINIB CITRATE (NON-STERILE API)

DMF 305782016

SUN PHARMACEUTICAL INDUSTRIES LTDTOFACITINIB CITRATE

DMF 306172016

MICRO LABS LTDTOFACITINIB CITRATE

DMF 306212016

UNICHEM LABORATORIES LTDTOFACITINIB CITRATE

DMF 306542016

OLON SPATOFACITINIB CITRATE

DMF 306862016

YABAO PHARMACEUTICAL GROUP CO LTDTOFACITINIB CITRATE

DMF 320352019

BEIJING MESOCHEM TECHNOLOGY CO LTDTOFACITINIB CITRATE

DMF 324452018

APOTEX INCTOFACITINIB CITRATE

DMF 325472018

DELMAR CHEMICALS INCTOFACITINIB CITRATE

DMF 333322018

BEIJING SJAR TECHNOLOGY DEVELOPMENT CO LTDTOFACITINIB CITRATE

DMF 341562019

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDTOFACITINIB CITRATE

DMF 351522020

PHARMABLOCK PHARMACEUTICALS (ZHEJIANG) CO LTDTOFACITINIB CITRATE

DMF 357132021

CHANGZHOU PHARMACEUTICAL FACTORYTOFACITINIB CITRATE

DMF 357462021

AURORE LIFE SCIENCES PRIVATE LTDTOFACITINIB CITRATE

DMF 358442021

METROCHEM API PRIVATE LTDTOFACITINIB CITRATE

DMF 359762021

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDTOFACITINIB CITRATE

DMF 362972021

HONOUR LAB LTDTOFACITINIB CITRATE

DMF 365422022

MATRIX PHARMACORP PRIVATE LTDTOFACITINIB CITRATE

DMF 365762021

INTAS PHARMACEUTICALS LTDTOFACITINIB CITRATE

DMF 371562022

DR REDDYS LABORATORIES LTDTOFACITINIB CITRATE

DMF 371642022

HUNAN WARRANT CHIRAL PHARMACEUTICAL CO LTDTOFACITINIB CITRATE

DMF 374712022

LEE PHARMA LTDTOFACITINIB CITRATE

DMF 374962022

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDTOFACITINIB CITRATE

DMF 375322022

MACLEODS PHARMACEUTICALS LTDTOFACITINIB CITRATE

DMF 385232023

METROCHEM API PRIVATE LTDTOFACITINIB CITRATE (PAI)

DMF 389942023

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDTOFACITINIB CITRATE NON-STERILE DRUG SUBSTANCE

DMF 400262024

SHANDONG JINCHENG KUNLUN PHARMACEUTICAL CO LTDTOFACITINIB CITRATE

DMF 413642025

SINTENOVO SA DE CVInactiveTOFACITINIB CITRATE

DMF 305542016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Jul 2, 2026	SUPPL -29	View Letter (PDF)
Mar 9, 2026	SUPPL -27	View Letter (PDF)
Feb 25, 2025	SUPPL -25	View Letter (PDF)
Sep 30, 2024	SUPPL -23	View Letter (PDF)
May 20, 2024	SUPPL -21	View Letter (PDF)
Dec 16, 2021	SUPPL -13	View Letter (PDF)
Dec 6, 2021	SUPPL -17	View Letter (PDF)
Dec 13, 2019	SUPPL -9	View Letter (PDF)
Sep 12, 2019	SUPPL -11	View Letter (PDF)
Jul 26, 2019	SUPPL -10	View Letter (PDF)
Oct 23, 2018	SUPPL -6	View Letter (PDF)
Aug 20, 2018	SUPPL -7	View Letter (PDF)
Dec 15, 2017	SUPPL -3	View Letter (PDF)
Feb 25, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 11MG BASE

RLDAB

3 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 23, 2016

Patents (3) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE41783	Dec 8, 2025PED: Jun 8, 2026	PED	Yes	—	—	—
9937181	Mar 14, 2034PED: Sep 14, 2034	PED	—	Yes	—	—
11253523	Mar 14, 2034PED: Sep 14, 2034	PED	—	—		—

#002 — EQ 22MG BASE

RLDAB

3 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 12, 2019