selumetinib sulfate · Astrazeneca · NDA 213756, 219943
Koselugo
Earliest generic entry, as listed · earliest of 4 marketed strengths
19 Nov 2032
Blocked by exclusivity: ODE*, ODE-545.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11813246 | product | 26 Mar 2029 |
| US 12220403 | product | 26 Mar 2029 |
| US 12318367 | product | 26 Mar 2029 |
| US 12364684 | use U-4357 | 26 Mar 2029 |
| US 7425637 | substance | 13 Mar 2028 |
| US 9156795 | substance, product | 12 Dec 2026 |
| US 9562017 | substance, use U-4357 | 12 Dec 2026 |
Exclusivities · 7 unexpired
| ODE* | 19 Nov 2032 | |
| ODE-545 | orphan drug (7 years) | 19 Nov 2032 |
| NPP | new patient population | 19 Nov 2028 |
| NP | new product | 10 Sep 2028 |
| NPP | new patient population | 10 Sep 2028 |
| ODE-288 | orphan drug (7 years) | 10 Apr 2027 |
| ODE* | 10 Apr 2027 |
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213756 · 001 · RLD | capsule, oral | EQ 10MG BASE | 19 Nov 2032 |
| 213756 · 002 · RLD | capsule, oral | EQ 25MG BASE | 19 Nov 2032 |
| 219943 · 001 · RLD | granule, oral | EQ 5MG BASE | 19 Nov 2032 |
| 219943 · 002 · RLD | granule, oral | EQ 7.5MG BASE | 19 Nov 2032 |
Expired or delisted (1)
- US 8178693 · substance, product · 13 Mar 2026