Prescription medicine
Deuruxolitinib Brand names: Leqselvi
Deuruxolitinib (Leqselvi) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the deuruxolitinib FDA label on DailyMed (effective July 13, 2026, Sun Pharmaceutical Industries, Inc.); the NDA 217900 record on Drugs@FDA; every deuruxolitinib label on DailyMed.
Highlights of the record
FDA label of July 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS.
Increased risk of serious bacterial, fungal, viral and opportunistic infections, including tuberculosis (TB), that may lead to hospitalization or death. Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. LEQSELVI treatment is not recommended in patients with active tuberculosis. Test for latent TB before and during therapy; 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, was observed with another Janus kinase (JAK) inhibitor vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients. ( 5.2 ) Malignancies were reported in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.3 ) Higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients. […]
Used for
From the label: indications and usageLEQSELVI™ is indicated for the treatment of adult patients with severe alopecia areata.
Forms and strengths
- 8 mg
Film-coated tablet.
On the market
- Earliest approval on file
- July 25, 2024 Leqselvi, Sun Pharm Inds Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 10, 2044 Leqselvi tablets; 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
What is deuruxolitinib used for?
From the label: indications and usageLEQSELVI™ is indicated for the treatment of adult patients with severe alopecia areata. Limitations of Use LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants. LEQSELVI is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata. ( 1 ) Limitations of Use: LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
FDA pharmacologic class: Janus Kinase Inhibitor.
Source: FDA drug label (LEQSELVI), Sun Pharmaceutical Industries, Inc., effective July 13, 2026 (SPL set a603f231-d09e-4bad-ad5e-b55f865da095), via openFDA; the full label on DailyMed
Is there a generic for deuruxolitinib (Leqselvi)?
No generic deuruxolitinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Leqselvi tablets: the compound patent runs to May 10, 2044, and the last listed entry to October 10, 2044. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2044 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What next?
- Other janus kinase inhibitors
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other