FDA Orange Book · active-ingredient family
Selumetinib sulfate
Selumetinib sulfate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:KOSELUGO · NDA 219943
2
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
16
Exclusivity periods
Brand (NDA) products · capsule, granule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KOSELUGORLD×2 | ASTRAZENECA | NDA 219943 | — | Sep 10, 2025 | |
| KOSELUGORLD×2 | ASTRAZENECA | NDA 213756 | — | Apr 10, 2020 |
Marketing exclusivity (16)
- NPPNew patient population exclusivity (3 years)
Sep 10, 2028
in 2 yr 3 mo
- NPPNew patient population exclusivity (3 years)
Nov 19, 2028
in 2 yr 5 mo
- ODE-288Orphan-drug exclusivity (7 years)
Apr 10, 2027
in 10 mo
- ODE-545Orphan-drug exclusivity (7 years)
Nov 19, 2032
in 6 yr 6 mo
- NPPNew patient population exclusivity (3 years)
Sep 10, 2028
in 2 yr 3 mo
- NPPNew patient population exclusivity (3 years)
Nov 19, 2028
in 2 yr 5 mo
- ODE-288Orphan-drug exclusivity (7 years)
Apr 10, 2027
in 10 mo
- ODE-545Orphan-drug exclusivity (7 years)
Nov 19, 2032
in 6 yr 6 mo
- NPNew product exclusivity (3 years)
Sep 10, 2028
in 2 yr 3 mo
- NPPNew patient population exclusivity (3 years)
Nov 19, 2028
in 2 yr 5 mo
- ODE*FDA marketing exclusivity
Apr 10, 2027
in 10 mo
- ODE*FDA marketing exclusivity
Nov 19, 2032
in 6 yr 6 mo
- NPNew product exclusivity (3 years)
Sep 10, 2028
in 2 yr 3 mo
- NPPNew patient population exclusivity (3 years)
Nov 19, 2028
in 2 yr 5 mo
- ODE*FDA marketing exclusivity
Apr 10, 2027
in 10 mo
- ODE*FDA marketing exclusivity
Nov 19, 2032
in 6 yr 6 mo
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8178693 | Mar 13, 2026 | 3 mo ago | SubstanceProduct |
| 9562017 | Dec 12, 2026 | in 6 mo | SubstanceU-4357 |
| 9156795 | Dec 12, 2026 | in 6 mo | SubstanceProduct |
| 7425637 | Mar 13, 2028 | in 1 yr 9 mo | Substance |
| 12364684 | Mar 26, 2029 | in 2 yr 10 mo | U-4357 |
| 11813246 | Mar 26, 2029 | in 2 yr 10 mo | Product |
| 12318367 | Mar 26, 2029 | in 2 yr 10 mo | Product |
| 12220403 | Mar 26, 2029 | in 2 yr 10 mo | Product |
Selumetinib sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
