FDA Orange Book
Is there a generic for Zydelig?
Zydelig contains idelalisib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zydelig (idelalisib). The Orange Book shows its last listed patent expires September 2, 2033.
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Zydelig products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 150MG | Marketed (Rx) | None | 0 | None |
NDA 205858, held by GILEAD SCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zydelig patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9492449 | March 11, 2030 | Method of use | U-1914 | 205858 |
| 8865730 | March 5, 2033 | Drug substance, Drug product | U-1615 | 205858 |
| 10730879 | March 5, 2033 | Drug substance, Drug product | None | 205858 |
| 9469643 | September 2, 2033 | Drug substance | None | 205858 |
Zydelig NDC codes
Questions
Is there a generic for Zydelig?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zydelig (idelalisib). The Orange Book shows its last listed patent expires September 2, 2033.
What is the generic name for Zydelig?
The active ingredient in Zydelig is idelalisib, per the FDA Orange Book.
When does the Zydelig patent expire?
The last patent listed for Zydelig in the Orange Book expires September 2, 2033. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.