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.
FDA has approved 1 generic application (ANDA) for Zydelig, though its earliest generic-entry date is 2 Sep 2033 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9469643 | drug substance · sets the listed date | 2 Sep 2033 |
| US 10730879 | drug substance, drug product | 5 Mar 2033 |
| US 8865730 | drug substance, drug 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
- First generic approved · ANDA 216921, Natco · 205858-001Approved 17 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 216921, Natco · 205858-001Approved 17 Feb 2026Detected 25 Oct 2026Historical import
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 |