Prescription medicine
Ritlecitinib Brand names: Litfulo
Ritlecitinib (Litfulo) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the ritlecitinib FDA label on DailyMed (effective June 17, 2026, Pfizer Laboratories Div Pfizer Inc); the NDA 215830 record on Drugs@FDA; every ritlecitinib label on DailyMed.
Highlights of the record
FDA label of June 17, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 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 that may lead to hospitalization or death, including tuberculosis (TB). Interrupt treatment if serious infection occurs until the infection is controlled. LITFULO should not be given to patients with active tuberculosis. Test for latent TB before and during therapy; start treating latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. ( 5.1 ). Monitor all patients for signs and symptoms of infection during and after treatment with LITFULO. ( 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. LITFULO is not approved for use in RA patients. ( 5.2 )
Malignancies were reported in patients treated with LITFULO ( 5.3 ). Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. […]
Used for
From the label: indications and usageLITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.
Forms and strengths
- 50 mg
Capsule.
On the market
- Earliest approval on file
- June 23, 2023 Litfulo, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- October 17, 2041 Litfulo capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,862 through July 30, 2026
What is ritlecitinib used for?
From the label: indications and usageLITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. ( 1 ) Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants ( 1 ).
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Litfulo), Pfizer Laboratories Div Pfizer Inc, effective June 17, 2026 (SPL set 6b2f9446-fb23-4741-b73a-5a2f993733c3), via openFDA; the full label on DailyMed
What does the patient leaflet for ritlecitinib 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 LITFULO?LITFULO may cause serious side effects, including: 1. Serious infections LITFULO is a medicine that affects your immune system. LITFULO can lower the ability of your immune system to fight infections. Some people have had serious infections while taking LITFULO or other similar medicines, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body and have been hospitalized. Some people taking similar medicines to LITFULO have died from these infections. • Your healthcare provider should test you for TB before starting treatment with LITFULO. • Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with LITFULO. You should not start taking LITFULO 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 (herpes zoster). Before starting LITFULO, tell your healthcare provider if you: • are being treated for an infection. • have an infection that has not gone away or that keeps coming back. • have diabetes, chronic lung disease, HIV, or a weak immune system. • have TB or have been in close contact with someone with TB. • have had shingles (herpes zoster). • have had hepatitis B or hepatitis 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 LITFULO. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common. […]
From the patient leaflet: How should I store LITFULO?Store LITFULO at room temperature between 68°F to 77°F (20°C to 25°C). • Keep LITFULO in the original package. • The LITFULO bottle has a child resistant closure and contains a cannister with a drying agent (desiccant). Do not eat the desiccant. Keep LITFULO and all medicines out of the reach of children.
Source: FDA drug label (Litfulo), Pfizer Laboratories Div Pfizer Inc, effective June 17, 2026 (SPL set 6b2f9446-fb23-4741-b73a-5a2f993733c3), via openFDA; the full label on DailyMed
Is there a generic for ritlecitinib (Litfulo)?
No generic ritlecitinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Litfulo capsules: the compound patent runs to October 17, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ritlecitinib label say about other medicines?
The ritlecitinib label names 1 other medicine 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 |
|---|---|---|
| Rifampin | drug interactions | Clinical Impact; Concomitant use of strong CYP3A inducer (e.g., rifampin) may decrease AUC and C max of ritlecitinib [see ], which may result in loss of or reduced clinical response. |
Source: FDA drug label (Litfulo), Pfizer Laboratories Div Pfizer Inc, effective June 17, 2026 (SPL set 6b2f9446-fb23-4741-b73a-5a2f993733c3), via openFDA; the full label on DailyMed
What do FAERS reports show for ritlecitinib?
The FDA Adverse Event Reporting System holds 1,862 reports that list ritlecitinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 86 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 next?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Ritlecitinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other