enzalutamide · Astellas · NDA 203415, 213674
Xtandi
Earliest generic entry, as listed · earliest of 3 marketed strengths
23 Feb 2037
Blocked by patent: US 12161628, US 12161628, US 12161628, US 12161628. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 12 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12161628 | use U-4102 | 23 Feb 2037 |
| US 12161628 | use U-4104 | 23 Feb 2037 |
| US 12161628 | use U-4103 | 23 Feb 2037 |
| US 12161628 | use U-4101 | 23 Feb 2037 |
| US 11839689 | product | 11 Sep 2033 |
| US 12447128 | use U-4313 | 11 Sep 2033 |
| US 12447128 | use U-4312 | 11 Sep 2033 |
| US 12447128 | use U-4314 | 11 Sep 2033 |
| US 12502357 | use U-4364 | 11 Sep 2033 |
| US 12502357 | use U-4363 | 11 Sep 2033 |
| US 12502357 | use U-4365 | 11 Sep 2033 |
| US 7709517 | substance, product | 13 Aug 2027 |
Exclusivities · 1 unexpired
| I-926 | new indication (3 years) | 17 Nov 2026 |
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 · 213674-00120 Apr 2026
- 25 Oct 2026Generic approved · 213674-00120 Apr 2026
- 24 Oct 2026Exclusivity expires within 90 days I-926 · 213674-00217 Nov 2026
- 24 Oct 2026Exclusivity expires within 90 days I-926 · 213674-00117 Nov 2026
- 24 Oct 2026Exclusivity expires within 90 days I-926 · 203415-00117 Nov 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 203415 · 001 · RLD | capsule, oral | 40MG | 23 Feb 2037 |
| 213674 · 001 · RLD | tablet, oral | 40MG | 23 Feb 2037 |
| 213674 · 002 · RLD | tablet, oral | 80MG | 23 Feb 2037 |
Expired or delisted (9)
- US 8183274 · use U-3763 · 24 Aug 2026
- US 8183274 · use U-1588 · 24 Aug 2026
- US 8183274 · use U-2708 · 24 Aug 2026
- US 8183274 · use U-2345 · 24 Aug 2026
- US 8183274 · use U-1281 · 24 Aug 2026
- US 9126941 · use U-1588 · 15 May 2026
- US 9126941 · use U-3763 · 15 May 2026
- US 9126941 · use U-2345 · 15 May 2026
- US 9126941 · use U-2708 · 15 May 2026