everolimus · Novartis · NDA 022334
Afinitor
Blocked by patent: US 9006224. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
FDA has approved 4 generic applications (ANDAs) for Afinitor, though its earliest generic-entry date is 1 Jul 2028 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 · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9006224 | use U-1681 | 1 Jul 2028 |
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 2026Generic approved · 022334-00125 Feb 2026
- 25 Oct 2026Generic approved · 022334-00112 May 2026
- 25 Oct 2026Generic approved · 022334-00130 Jun 2026
- 25 Oct 2026Generic approved · 022334-00130 Oct 2025
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022334 · 001 · RLD | tablet, oral | 5MG | 1 Jul 2028 |
| 022334 · 002 · RLD | tablet, oral | 10MG | 1 Jul 2028 |
| 022334 · 003 · RLD | tablet, oral | 2.5MG | 1 Jul 2028 |
| 022334 · 004 · RLD | tablet, oral | 7.5MG | 1 Jul 2028 |
Expired or delisted (2)
- US 8410131 · — · 1 May 2026
- US 8410131 · use U-1368 · 1 Nov 2025