FDA Orange Book · active-ingredient family
Trametinib dimethyl sulfoxide
Trametinib dimethyl sulfoxide is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
2
Brand (NDA)
1
Generics (ANDA)
16
Listed patents
16
Exclusivity periods
Brand (NDA) products · solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MEKINISTRLD | NOVARTIS | NDA 217513 | — | Mar 16, 2023 | |
| MEKINISTRLD×3 | NOVARTIS | NDA 204114 | — | May 29, 2013 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRAMETINIB DIMETHYL SULFOXIDE×2 | HIKMA | ANDA 219002 | — | Aug 06, 2024 |
Marketing exclusivity (16)
- NPNew product exclusivity (3 years)
Mar 16, 2026
3 mo ago
- ODE-428Orphan-drug exclusivity (7 years)
Mar 16, 2030
in 3 yr 10 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 16, 2030
in 4 yr 4 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 16, 2026
in 3 mo
- I-908New indication exclusivity (3 years)
Mar 16, 2026
3 mo ago
- ODE-428Orphan-drug exclusivity (7 years)
Mar 16, 2030
in 3 yr 10 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 16, 2026
in 3 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 16, 2030
in 4 yr 4 mo
- I-908New indication exclusivity (3 years)
Mar 16, 2026
3 mo ago
- ODE-428Orphan-drug exclusivity (7 years)
Mar 16, 2030
in 3 yr 10 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 16, 2026
in 3 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 16, 2030
in 4 yr 4 mo
- I-908New indication exclusivity (3 years)
Mar 16, 2026
3 mo ago
- ODE-428Orphan-drug exclusivity (7 years)
Mar 16, 2030
in 3 yr 10 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 16, 2026
in 3 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 16, 2030
in 4 yr 4 mo
Listed patents (16)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7378423 | May 29, 2027 | in 11 mo | SubstanceProduct |
| 7378423*PED | Nov 29, 2027 | in 1 yr 6 mo | |
| 8703781 | Oct 15, 2030 | in 4 yr 5 mo | SubstanceProductU-3564 |
| 8952018 | Oct 15, 2030 | in 4 yr 5 mo | U-2020 |
| 8703781*PED | Apr 15, 2031 | in 4 yr 11 mo | |
| 8952018*PED | Apr 15, 2031 | in 4 yr 11 mo | |
| 8580304 | Jan 28, 2032 | in 5 yr 8 mo | Product |
| 9399021 | Jan 28, 2032 | in 5 yr 8 mo | Product |
| 9155706 | Jan 28, 2032 | in 5 yr 8 mo | Product |
| 9271941 | Jan 28, 2032 | in 5 yr 8 mo | Product |
| 8580304*PED | Jul 28, 2032 | in 6 yr 2 mo | |
| 9155706*PED | Jul 28, 2032 | in 6 yr 2 mo | |
| 9271941*PED | Jul 28, 2032 | in 6 yr 2 mo | |
| 9399021*PED | Jul 28, 2032 | in 6 yr 2 mo | |
| 10869869 | Aug 30, 2033 | in 7 yr 4 mo | U-3184 |
| 10869869*PED | Feb 28, 2034 | in 7 yr 10 mo |
Trametinib dimethyl sulfoxide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
