nilotinib hydrochloride · Novartis · NDA 022068
Tasigna
Earliest generic entry, as listed · earliest of 3 marketed strengths
7 Oct 2032
Blocked by patent: US 9061029.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9061029 | — | 7 Oct 2032 |
| US 9061029 | substance, use U-3231 | 7 Apr 2032 |
| US 9061029 | substance, use U-1374 | 7 Apr 2032 |
| US 8163904 | — | 23 Feb 2029 |
| US 8163904 | substance, product | 23 Aug 2028 |
| US 8293756 | — | 25 Mar 2028 |
| US 8293756 | product | 25 Sep 2027 |
| US 8389537 | — | 18 Jan 2027 |
| US 8415363 | — | 18 Jan 2027 |
| US 8501760 | — | 18 Jan 2027 |
Exclusivities · 2 unexpired
| PED | pediatric (6 months added) | 23 Mar 2029 |
| ODE-380 | orphan drug (7 years) | 23 Sep 2028 |
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 · 022068-00119 Nov 2025
- 25 Oct 2026Generic approved · 022068-00119 Nov 2025
- 25 Oct 2026Generic approved · 022068-00119 Nov 2025
- 25 Oct 2026Generic approved · 022068-00126 Jun 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022068 · 001 · RLD | capsule, oral | EQ 200MG BASE | 7 Oct 2032 |
| 022068 · 002 · RLD | capsule, oral | EQ 150MG BASE | 7 Oct 2032 |
| 022068 · 003 · RLD | capsule, oral | EQ 50MG BASE | 7 Oct 2032 |
Expired or delisted (4)
- US 8389537 · use U-1374 · 18 Jul 2026
- US 8415363 · substance, product, use U-1374 · 18 Jul 2026
- US 8415363 · substance, product, use U-1407 · 18 Jul 2026
- US 8501760 · product · 18 Jul 2026