Help paying · Medicare negotiated price · pharmacy cost · cycle 2028
Xeljanz (tofacitinib): where help paying exists, where Medicare's negotiation stands and what pharmacies pay
A program that covered this drug has changed its terms; the details and the source are below. CMS has selected Xeljanz for the 2028 negotiation cycle. The CMS file we read (November 6, 2026) lists its negotiated price as taking effect January 1, 2028 and holds no price for it yet, so this page shows no negotiated price. 9 non-manufacturing label changes are dated in the last 12 months in the FDA's file. ClinicalTrials.gov lists 28 recruiting trials that name tofacitinib.
Every package CMS lists
Packages the CMS file lists for Xeljanz, with NADAC per unit where the benchmark has one (per unit, as the files state).
| NDC | Product | Unit | CMS price status | NADAC |
|---|---|---|---|---|
| 00069-0501-14 | (name not listed) | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 00069-0501-30 | XELJANZ TOFACTINIB 11MG ER TABLET | EA | Selected; price takes effect January 1, 2028, not yet published | $208 |
| 00069-0502-30 | (name not listed) | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 00069-1001-01 | XELJANZ TOFACTINIB 5MG TABLET | EA | Selected; price takes effect January 1, 2028, not yet published | $73.77 |
| 00069-1001-02 | (name not listed) | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 00069-1001-03 | (name not listed) | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 00069-1002-01 | XELJANZ 10MG X 60 TAB US | EA | Selected; price takes effect January 1, 2028, not yet published | $104 |
| 00069-1002-02 | (name not listed) | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 00069-1002-03 | (name not listed) | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 00069-1029-01 | (name not listed) | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 00069-1029-02 | (name not listed) | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 63539-0501-14 | (name not listed) | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
When could a generic arrive
Each date below is an upper bound from listed patent and exclusivity dates, not a forecast of when a generic will launch. Basis: latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled).
| Application | Product | Latest listed patent expiry | Latest listed exclusivity expiry | Latest of the two | Set by |
|---|---|---|---|---|---|
| NDA203214 | Xeljanz 10mg X 60 Tab Us, Xeljanz Tofactinib 5mg Tablet | June 8, 2026 | August 21, 2028 | August 21, 2028 | exclusivity code PED; 6 dated entries listed |
| NDA208246 | Xeljanz Tofactinib 11mg Er Tablet, Xeljanz Xr 22mg Tab 1x30 Btl Us | September 14, 2034 | none listed | September 14, 2034 | patent 10639309 with its pediatric extension; 12 dated entries listed |
| NDA213082 | Xeljanz 1mg/ml Orsol 1x240ml Pbtl Us | June 8, 2026 | August 21, 2028 | August 21, 2028 | exclusivity code PED; 4 dated entries listed |
Source: FDA Orange Book data files, edition September 2026, read November 7, 2026; patent listings are as submitted by applicants and not verified by FDA. FDA data file.
Medicare Part D spending
CMS's Medicare Part D spending dataset reports gross spending on Xeljanz of $589.79 million in 2024, across 94,342 claims and 12,581 beneficiaries. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.
| Year | Gross spending | Claims | Beneficiaries | Average spending per claim |
|---|---|---|---|---|
| 2024 | $589.79 million | 94,342 | 12,581 | $6,252 |
| 2023 | $585.77 million | 94,068 | 12,497 | $6,227 |
| 2022 | $591.11 million | 101,614 | 13,973 | $5,817 |
| 2021 | $625.71 million | 114,780 | 16,384 | $5,451 |
| 2020 | $575.32 million | 107,616 | 16,039 | $5,346 |
Source: CMS Medicare Part D spending by drug (data-year-2024, modified 2026-06-25), read November 7, 2026. CMS dataset page. All manufacturers combined; the figures are a drug-level aggregate of claims and say nothing about a formulary or coverage.
FDA safety program (REMS)
- Xeljanz (application NDA203214): listed as released, without Elements to Assure Safe Use. Program dated November 6, 2012, last modified February 8, 2016. REMS@FDA program page.
A REMS is a safety program the FDA can require for a drug. Some restrict how it is prescribed or dispensed, for example through certified prescribers or pharmacies. This lists what the FDA's REMS@FDA files tie to the application; it does not say which prescribers or pharmacies take part, or whether a given patient needs the program.
Source: FDA REMS@FDA data files (rems-fda-files-2026-11-07-products-20a9945448dd), read November 7, 2026. REMS@FDA product file.
Medicaid use by state
CMS's State Drug Utilization Data records, for 2025, how many prescriptions each state's Medicaid program paid for under this drug's packages and what it reimbursed. The 8 states with the largest reimbursement are shown. Reimbursement is before the rebates manufacturers pay states, so it is not a net cost and not a price a patient pays.
| State | Medicaid-paid prescriptions | Medicaid reimbursed | Covers |
|---|---|---|---|
| CT | 119 | $862,106 | All record types |
| ND | 99 | $793,792 | All record types |
| RI | 70 | $408,330 | All record types |
| AR | 63 | $327,888 | Fee-for-service only |
| DC | 56 | $311,373 | All record types |
| MO | 58 | $266,998 | All record types |
| KY | 54 | $253,185 | All record types |
| WA | 56 | $239,533 | Fee-for-service only |
Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (2 state and package figures are marked that way here). A state missing from the table means its figures were suppressed or not reported, not zero use. 113 older-year figures are held and left out of the table.
Source: CMS State Drug Utilization Data (State Drug Utilization Data 2025, modified 2026-07-13T15:28:32Z), read November 7, 2026. CMS dataset page. State-reported data compiled by CMS; aggregate by state and package, no provider or patient data.
FDA drug safety communication
The most recent FDA Drug Safety Communication that names tofacitinib is dated February 4, 2021: Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib). It is the FDA's own dated notice, listed as published. OmniRx does not interpret it or say whether it applies to your treatment.
Source: FDA Drug Safety Communications, read November 7, 2026.
Where help paying exists
No program in our finder currently lists this drug as open to new patients.
Label changes
FDA actions on the applications behind Xeljanz dated since November 11, 2025, leaving out manufacturing (CMC) changes. 9 changes in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| September 16, 2026 | Labeling | NDA203214 | 42 | Label (PDF) posted September 22, 2026FDA letter posted September 21, 2026 |
| September 16, 2026 | Labeling | NDA208246 | 28 | Label (PDF) posted September 22, 2026FDA letter posted September 21, 2026 |
| September 16, 2026 | Labeling | NDA213082 | 15 | Label (PDF) posted September 22, 2026FDA letter posted September 21, 2026 |
| June 30, 2026 | Labeling | NDA203214 | 43 | Label (PDF) posted July 6, 2026FDA letter posted July 2, 2026 |
| June 30, 2026 | Labeling | NDA208246 | 29 | Label (PDF) posted July 6, 2026FDA letter posted July 2, 2026 |
| June 30, 2026 | Labeling | NDA213082 | 16 | Label (PDF) posted July 6, 2026FDA letter posted July 2, 2026 |
| March 6, 2026 | Efficacy | NDA203214 | 41 | Label (PDF) posted March 11, 2026FDA letter posted March 9, 2026 |
| March 6, 2026 | Efficacy | NDA208246 | 27 | Label (PDF) posted March 11, 2026FDA letter posted March 9, 2026 |
| March 6, 2026 | Efficacy | NDA213082 | 13 | Label (PDF) posted March 11, 2026FDA letter posted March 9, 2026 |
Source: FDA Drugs@FDA data file, read November 7, 2026. Dates are the FDA action dates; the documents are on FDA's own site. FDA data file. All recent changes across these drugs: label changes feed.
Clinical trials recruiting
ClinicalTrials.gov lists 28 interventional trials that name tofacitinib and are recruiting, and 11 more not yet recruiting. By phase: Phase 4: 10, Phase 2: 7, Not applicable: 5, Phase 3: 4, Phase 1: 1, Early phase 1: 1. The 10 most recently updated are below. A listing is not an offer of free drug and not medical advice. Whether a trial fits is decided by the study team and your own clinician.
| Trial | Title and conditions | Phase | Lead sponsor | Last updated | Countries |
|---|---|---|---|---|---|
| NCT07281456 | Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren DiseaseSjogren's Syndrome | Phase 2 | National Institute of Dental and Craniofacial Research (NIDCR) | November 2, 2026 | United States |
| NCT06654882 | Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic ArthritisPolyarticular Course Juvenile Idiopathic Arthritis (JIA) | Phase 3 | Duke University | October 21, 2026 | United States, Germany, Italy and 1 more |
| NCT07843693 | A Study to Evaluate the Safety and Pharmacokinetics of Multiple Doses Upadacitinib, Tofacitinib, and Baricitinib in Healthy Adult VolunteersHealthy Volunteers | Phase 1 | AbbVie | September 28, 2026 | United States |
| NCT04692493 | RA-PRO PRAGMATIC TRIALRheumatoid Arthritis | Phase 3 | University of Alabama at Birmingham | September 24, 2026 | United States, Canada |
| NCT07598643 | Modulation of the Immune System in Down Syndrome for Improved Outcomes and Neurodevelopment - 1Down Syndrome | Phase 2 | University of Colorado, Denver | September 3, 2026 | United States |
| NCT07406035 | A Clinical Trial of TQH3906 Capsules in the Treatment of Active Psoriatic ArthritisPsoriatic Arthritis | Phase 2 | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | September 2, 2026 | China |
| NCT06687551 | JAK Inhibitor Dose TAPering Strategy StudyRheumatoid Arthritis (RA | Phase 4 | University Hospital, Toulouse | August 7, 2026 | France |
| NCT07721142 | Integrated Clinical Study of Traditional Chinese and Western Medicine for Refractory Rheumatoid ArthritisRheumatoid Arthritis (RA) | Phase 4 | Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine | July 22, 2026 | China |
| NCT06698822 | A Phase 2 Trial to Assess Safety and Efficacy of Tofacitinib 2% Cream in the Treatment of Cutaneous T-cell Lymphoma (CTCL), Stages IA, IB, and IIACutaneous T-Cell Lymphoma | Phase 2 | M.D. Anderson Cancer Center | July 13, 2026 | United States |
| NCT07138898 | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder ArthroplastyRheumatic Disease | Phase 2 | NYU Langone Health | July 9, 2026 | United States |
Source: ClinicalTrials.gov, registry data processed November 6, 2026, summarized and trimmed by OmniRx. Search on ClinicalTrials.gov.
Questions
What is the Medicare negotiated price of Xeljanz?
CMS has selected Xeljanz for the 2028 negotiation cycle. The CMS file we read (November 6, 2026) lists its negotiated price as taking effect January 1, 2028 and holds no price for it yet, so this page shows no negotiated price. When CMS publishes a price it will be a Medicare Part D price agreed with the manufacturer, not what a person pays at the counter.
How does the negotiated price compare with what pharmacies pay?
No negotiated price is published yet, so there is nothing to compare with the pharmacy acquisition benchmark.
Is there help paying for Xeljanz?
No program in our finder currently lists it as open to new patients. Pfizer RxPathways lists the products that remain in its Patient Assistance Program as of January 1, 2026, and marks Xeljanz and Bosulif as taking no new patients starting July 1, 2026. The page also notes the product list is subject to change.
When could a generic version of Xeljanz arrive?
For Xeljanz, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA203214, August 21, 2028; NDA208246, September 14, 2034; NDA213082, August 21, 2028. Each date is an upper bound from listed patent and exclusivity dates, not a forecast of when a generic will launch. Basis: latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled).
Can I join a clinical trial for Xeljanz?
ClinicalTrials.gov lists 28 recruiting interventional trials that name tofacitinib (registry data processed November 6, 2026). A listing is not an offer of free drug and not medical advice. Whether a trial fits is decided by the study team and your own clinician.
How much does Medicare Part D spend on Xeljanz?
CMS's Medicare Part D spending dataset reports gross spending on Xeljanz of $589.79 million in 2024, across 94,342 claims and 12,581 beneficiaries. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.
For developers: this drug as data
One call returns price, generic-entry upper bound, label history, recalls, trials, assistance, and where facts exist the FDA safety program (REMS), DEA schedule, orphan designations, safety notices and Medicaid use by state, each with receipts.
Example file: https://omnirx.org/api/v1/dossier/xeljanz.json
The licence page sets out what a data licence covers, and the API page documents these files.
Evaluation files with receipts; contract may change; not clinical advice.
Sources and terms. CMS Medicare Drug Price Negotiation Program data file (read November 6, 2026; the CMS page states no licence or restriction); CMS NADAC from data.medicaid.gov under the labels in the OmniRx licence ledger; program details read from each program's own pages; CMS Medicare Part D spending by drug; FDA Drugs@FDA and Orange Book data files; ClinicalTrials.gov registry data. Figures are stored with their sources in the OmniRx library (edition 2026-11). Free to cite with attribution. Not medical, legal or financial advice. Report an error through the contact page. Licence the data.