# ZYDELIG — FDA application NDA205858

Informational only - not investment advice.

Application NDA205858 · type NDA · FDA status: approved · original approval 2014-07-23

Listed sponsor: GILEAD SCIENCES INC · [GILD company profile](/company/GILD/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | ZYDELIG | IDELALISIB | TABLET | ORAL | 100MG | Prescription | AB | Yes |
| 002 | ZYDELIG | IDELALISIB | TABLET | ORAL | 150MG | Prescription | AB | Yes |

## Orange Book patent and exclusivity listings

- Patent 9492449, product 001; listed patent expiry date: 2030-03-11.
- Patent 9492449, product 002; listed patent expiry date: 2030-03-11.
- Patent 10730879, product 001; listed patent expiry date: 2033-03-05.
- Patent 10730879, product 002; listed patent expiry date: 2033-03-05.
- Patent 8865730, product 001; listed patent expiry date: 2033-03-05.
- Patent 8865730, product 002; listed patent expiry date: 2033-03-05.
- Patent 9469643, product 001; listed patent expiry date: 2033-09-02.
- Patent 9469643, product 002; listed patent expiry date: 2033-09-02.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- IDELALISIB · UNII YG57I8T5M0 · [lmmol compound IFSDAJWBUCMOAH-HNNXBMFYSA-N](https://lmmol.com/compound/IFSDAJWBUCMOAH-HNNXBMFYSA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/GILD/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA205858. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.