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PlainMeds

Prescription medicine

Leniolisib Brand names: Joenja

Leniolisib (Joenja) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the leniolisib FDA label on DailyMed (effective June 5, 2025, Pharming Healthcare Inc.); the NDA 217759 record on Drugs@FDA; every leniolisib label on DailyMed.

Highlights of the record

FDA label of June 5, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

JOENJA is indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.

Forms and strengths

  • 40 mg
  • 50 mg
  • 70 mg

Film-coated tablet.

On the market

Earliest approval on file
March 24, 2023 Joenja, Pharming; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
February 19, 2032 Joenja 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 leniolisib used for?

From the label: indications and usage

JOENJA is indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older. JOENJA is a kinase inhibitor indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.

FDA pharmacologic class: Kinase Inhibitor.

Source: FDA drug label (Joenja), Pharming Healthcare Inc., effective June 5, 2025 (SPL set eefbcef8-2130-4654-8f29-b58077e08212), via openFDA; the full label on DailyMed

Is there a generic for leniolisib (Joenja)?

No generic leniolisib is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 1 patent for Joenja tablets: the compound patent runs to February 19, 2032. 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
  • 2032 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the leniolisib label say about other medicines?

The leniolisib 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 namedSectionWhat the label says
Itraconazoledrug interactionsLeniolisib exposure was increased 2-fold when co-administered with itraconazole, a strong CYP3A4 inhibitor [see Clinical Pharmacology ( 12.3 )].

Check leniolisib against other medicines

Source: FDA drug label (Joenja), Pharming Healthcare Inc., effective June 5, 2025 (SPL set eefbcef8-2130-4654-8f29-b58077e08212), via openFDA; the full label on DailyMed

What next?

Other kinase inhibitors
the pharmacologic class, with prices and generics
Check an interaction
what two or more labels say about each other