Prescription medicine
Duvelisib Brand names: Copiktra
Duvelisib (Copiktra) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the duvelisib FDA label on DailyMed (effective December 18, 2025, Secura Bio, Inc); the NDA 211155 record on Drugs@FDA; every duvelisib label on DailyMed.
Highlights of the record
FDA label of December 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
TREATMENT-RELATED MORTALITY AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, AND PNEUMONITIS.
Treatment-related mortality occurred in 15% of COPIKTRA-treated patients [see Warnings and Precautions ( 5.1 )]. Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected [see Warnings and Precautions ( 5.2 )]. Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA [see Warnings and Precautions ( 5.3 )]. Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA [see Warnings and Precautions ( 5.4 )]. Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA [see Warnings and Precautions ( 5.5 )]. WARNING: TREATMENT-RELATED MORTALITY AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS See full prescribing information for complete boxed warning Treatment-related mortality occurred in 15% of COPIKTRA-treated patients. ( 5.1 ) Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. […]
Used for
From the label: indications and usageCOPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy.
Forms and strengths
- 15 mg
- 25 mg
Capsule.
On the market
- Earliest approval on file
- September 24, 2018 Copiktra, Secura; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- April 26, 2035 Copiktra 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
- 765 through July 30, 2026
What is duvelisib used for?
From the label: indications and usageCOPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines lines of systemic therapy. […]
Conditions named in the indications of duvelisib's FDA labels, with every medicine labeled for each:
Source: FDA drug label (COPIKTRA), Secura Bio, Inc, effective December 18, 2025 (SPL set e3c5ac56-e1f6-473a-bc73-687836534780), via openFDA; the full label on DailyMed
What does the patient leaflet for duvelisib 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 COPIKTRA?COPIKTRA can cause serious side effects, including: Death due to treatment side effects. COPIKTRA can cause severe, life-threatening side effects that can lead to death. The serious side effects are listed below. Infections were the most common cause of death. If you develop any of these or any new or worsening side effects, tell your healthcare provider right away. Infections. Infections are common during COPIKTRA treatment, and can be serious and can lead to death. Tell your healthcare provider right away if you have a fever, chills, or other signs of an infection during treatment with COPIKTRA. Diarrhea or inflammation of your intestine. Diarrhea or inflammation of your intestine (colitis) is common during COPIKTRA treatment, and can be serious and can lead to death. Your healthcare provider may prescribe an anti-diarrhea medicine for your diarrhea. Tell your healthcare provider right away if you have any new or worsening diarrhea, stool with mucus or blood, or if you have severe stomach-area (abdominal) pain. Your healthcare provider should prescribe medicine to help your diarrhea and check you at least weekly. If your diarrhea is severe or anti-diarrhea medicines did not work, you may need treatment with a steroid medicine. Skin reactions. Rashes are common with COPIKTRA treatment. COPIKTRA can cause rashes and other skin reactions that can be serious and can lead to death. […]
From the patient leaflet: How should I store COPIKTRA?Store COPIKTRA at room temperature between 68°F to 77°F (20°C to 25°C). Keep COPIKTRA in its original container until you are ready to take your dose. Keep COPIKTRA and all medicines out of the reach of children.
Source: FDA drug label (COPIKTRA), Secura Bio, Inc, effective December 18, 2025 (SPL set e3c5ac56-e1f6-473a-bc73-687836534780), via openFDA; the full label on DailyMed
Is there a generic for duvelisib (Copiktra)?
No generic duvelisib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Copiktra capsules: the compound patent runs to September 24, 2032, and the last listed entry to April 26, 2035. 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
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the duvelisib label say about other medicines?
The duvelisib 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 |
|---|---|---|
| Budesonide | warnings and precautions | If the diarrhea is unresponsive to antidiarrheal therapy, withhold COPIKTRA and initiate supportive therapy with enteric acting steroids (e.g., budesonide). |
Source: FDA drug label (COPIKTRA), Secura Bio, Inc, effective December 18, 2025 (SPL set e3c5ac56-e1f6-473a-bc73-687836534780), via openFDA; the full label on DailyMed
What do FAERS reports show for duvelisib?
The FDA Adverse Event Reporting System holds 765 reports that list duvelisib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 173 are coded as a death and 252 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 duvelisib?
37 other medicines are given the same way (oral) and in the same FDA class as duvelisib or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 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 |
|---|---|---|---|---|
| Lenalidomide | Leukemia, lymphoma and myeloma | 18 labelers | n/a | No current entry |
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Pomalidomide | Leukemia, lymphoma and myeloma | 11 labelers | n/a | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | none listed | n/a | A presentation being discontinued |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Hydroxyurea | Leukemia, lymphoma and myeloma | 10 labelers | $0.184 per capsule 500 mg capsule | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 4 labelers | $1.67 per capsule 50 mg capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Duvelisib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other