Prescription medicine
Idelalisib Brand names: Zydelig
Idelalisib (Zydelig) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.
- No generic listed
- A presentation discontinued
Check it at the source: idelalisib labels on DailyMed; the NDA 205858 record on Drugs@FDA; every idelalisib label on DailyMed.
Highlights of the record
no current FDA label; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
The label in openFDA carries no indications section.
Forms and strengths
- 100 mg
- 150 mg
Film-coated tablet.
On the market
- Earliest approval on file
- July 23, 2014 Zydelig, Gilead Sciences Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first February 17, 2026; 0 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
- September 2, 2033 Zydelig tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- No recall recorded
Is there a generic for idelalisib (Zydelig)?
The FDA approved the first generic idelalisib on February 17, 2026. 1 generic application is approved; 0 of it carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 4 patents for Zydelig tablets: the compound patent runs to September 2, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2026 first generic approved
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is idelalisib in shortage?
No idelalisib presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated April 7, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Zydelig, Tablet, 100 mg (NDC 61958-1701-1) | Gilead Sciences, Inc. | To Be Discontinued | April 7, 2026 |
| Zydelig, Tablet, 150 mg (NDC 61958-1702-1) | Gilead Sciences, Inc. | To Be Discontinued | April 7, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the idelalisib label say about other medicines?
The idelalisib label names no other medicine on this site. The labels of 2 other medicines name idelalisib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name idelalisib
Source: FDA drug label, labeler not named, effective (SPL set ), via openFDA; the full label on DailyMed
What next?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Idelalisib shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other