idelalisib · Gilead Sciences Inc · NDA 205858
Zydelig
Earliest generic entry, as listed · earliest of 2 marketed strengths
2 Sep 2033
Blocked by patent: US 9469643.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9469643 | substance | 2 Sep 2033 |
| US 10730879 | substance, product | 5 Mar 2033 |
| US 8865730 | substance, product, use U-1615 | 5 Mar 2033 |
| US 9492449 | use U-1914 | 11 Mar 2030 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 25 Oct 2026First generic approved · 205858-00117 Feb 2026
- 25 Oct 2026Generic approved · 205858-00117 Feb 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205858 · 001 · RLD | tablet, oral | 100MG | 2 Sep 2033 |
| 205858 · 002 · RLD | tablet, oral | 150MG | 2 Sep 2033 |