Prescription medicine
Baricitinib Brand names: Olumiant
Baricitinib (Olumiant) is a prescription medicine with an FDA approval on record since 2018. No generic is listed; pharmacies paid $92.54 per Olumiant 2 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the baricitinib FDA label on DailyMed (effective June 30, 2026, Eli Lilly and Company); the NDA 207924 record on Drugs@FDA; every baricitinib label on DailyMed.
Highlights of the record
FDA label of June 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE),.
and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See full prescribing information for complete boxed warning. Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with OLUMIANT if serious infection occurs until the infection is controlled. OLUMIANT should not be given to patients with active tuberculosis. Test for latent TB before and during therapy, except for COVID-19; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. ( 5.1 ) Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. ( 5.2 ) Malignancies have occurred in patients treated with OLUMIANT. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.3 ) Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.4 ) Thrombosis has occurred in patients treated with OLUMIANT. […]
Used for
From the label: indications and usageOLUMIANT ® is a Janus kinase (JAK) inhibitor indicated for: the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers.
Forms and strengths
- 1 mg
- 2 mg
- 4 mg
Film-coated tablet.
On the market
- Earliest approval on file
- May 31, 2018 Olumiant, Eli Lilly And Co; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first July 22, 2024; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 30, 2032 Olumiant tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $92.54 per tablet Olumiant 2 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 9,585 through July 30, 2026
What is baricitinib used for?
From the label: indications and usageOLUMIANT ® is a Janus kinase (JAK) inhibitor indicated for: the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers. ( 1.1 ) Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ( 1.1 ) the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. ( 1.2 ) the treatment of adult patients with severe alopecia areata. […]
Conditions named in the indications of baricitinib's FDA labels, with every medicine labeled for each:
From other baricitinib labelsRheumatoid arthritis: Rheumatoid Arthritis OLUMIANT ® (baricitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
COVID-19: Coronavirus Disease 2019 (COVID-19) OLUMIANT is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal …
FDA pharmacologic class: Janus Kinase Inhibitor.
Source: FDA drug label (Olumiant), Eli Lilly and Company, effective June 30, 2026 (SPL set 866e9f35-9035-4581-a4b1-75a621ab55cf), via openFDA; the full label on DailyMed
What does the patient leaflet for baricitinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about OLUMIANT?OLUMIANT may cause serious side effects, including: 1. Serious infections. OLUMIANT is a medicine that affects your immune system. OLUMIANT can lower the ability of your immune system to fight infections. Some people have had serious infections while taking OLUMIANT, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting treatment with OLUMIANT for rheumatoid arthritis or alopecia areata. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with OLUMIANT. You should not start taking OLUMIANT if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles. Before starting OLUMIANT, tell your healthcare provider if you: are being treated for an infection have an infection that does not go away or that keeps coming back have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections have TB or have been in close contact with someone with TB have had shingles (herpes zoster) have had hepatitis B or C live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or become more severe if you use OLUMIANT. […]
From the patient leaflet: How should I store OLUMIANT?Store OLUMIANT at room temperature between 68°F to 77°F (20°C to 25°C). Keep OLUMIANT and all medicines out of the reach of children. General Information about the safe and effective use of OLUMIANT. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use OLUMIANT for a condition for which it was not prescribed. Do not give OLUMIANT to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about OLUMIANT that is written for health professionals.
Source: FDA drug label (Olumiant), Eli Lilly and Company, effective June 30, 2026 (SPL set 866e9f35-9035-4581-a4b1-75a621ab55cf), via openFDA; the full label on DailyMed
Is there a generic for baricitinib (Olumiant)?
The FDA approved the first generic baricitinib on July 22, 2024. 2 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 6 patents for Olumiant tablets: the compound patent runs to May 31, 2032, and the last listed entry to November 30, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2024 first generic approved
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for baricitinib (Olumiant)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $92.54 per Olumiant 2 mg tablet, up 3% from $89.78 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Olumiant 2 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Olumiant 2 mg tablet | Brand | $92.54 per tablet | $2,776.30 | +3% |
| Olumiant 4 mg tablet | Brand | $184.66 per tablet | $5,539.87 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the baricitinib label say about other medicines?
The baricitinib label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Methotrexate | boxed warning | Most patients with rheumatoid arthritis who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. |
| Probenecid | drug interactions | DRUG INTERACTIONS In patients taking strong Organic Anion Transporter 3 (OAT3) inhibitors (e.g., probenecid) the recommended dosage should be reduced. |
Source: FDA drug label (Olumiant), Eli Lilly and Company, effective June 30, 2026 (SPL set 866e9f35-9035-4581-a4b1-75a621ab55cf), via openFDA; the full label on DailyMed
What do FAERS reports show for baricitinib?
The FDA Adverse Event Reporting System holds 9,585 reports that list baricitinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 877 are coded as a death and 3,139 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as baricitinib?
9 other medicines are given the same way (oral) and in the same FDA class as baricitinib or labeled mainly for the same use (rheumatoid arthritis), the same class first. Rheumatoid arthritis lists all 46 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Tofacitinib | Rheumatoid arthritis | 24 labelers | $0.573 per tablet 5 mg tablet | No current entry |
| Upadacitinib | Rheumatoid arthritis | none listed | $229.31 per tablet 15 mg tablet | No current entry |
| Indomethacin | Rheumatoid arthritis | 25 labelers | $0.210 per capsule 75 mg capsule | No current entry |
| Hydroxychloroquine | Rheumatoid arthritis | 28 labelers | $0.149 per tablet 200 mg tablet | A presentation being discontinued |
| Leflunomide | Rheumatoid arthritis | 16 labelers | $0.324 per tablet 10 mg tablet | A presentation being discontinued |
| Methotrexate | Rheumatoid arthritis | 25 labelers | $0.158 per tablet 2.5 mg tablet | In shortage |
| Penicillamine | Rheumatoid arthritis | 9 labelers | n/a | No current entry |
| Flurbiprofen | Rheumatoid arthritis | 3 labelers | $3.17 per tablet 100 mg tablet | No current entry |
Every medicine labeled for the same conditions as baricitinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to baricitinib
- 9 medicines for the same use
- Other janus kinase inhibitors
- the pharmacologic class, with prices and generics
- Baricitinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other