FDA Orange Book · active-ingredient family
Dabrafenib mesylate
Dabrafenib mesylate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:TAFINLAR · NDA 217514
2
Brand (NDA)
0
Generics (ANDA)
14
Listed patents
12
Exclusivity periods
Brand (NDA) products · capsule, tablet, for suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TAFINLARRLD | NOVARTIS | NDA 217514 | — | Mar 16, 2023 | |
| TAFINLARRLD×2 | NOVARTIS | NDA 202806 | — | May 29, 2013 |
Marketing exclusivity (12)
- 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, 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, 2030
in 4 yr 4 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 16, 2026
in 3 mo
- 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
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9233956 | May 04, 2029 | in 2 yr 11 mo | U-2032 |
| 9233956*PED | Nov 04, 2029 | in 3 yr 5 mo | |
| 7994185 | Jan 20, 2030 | in 3 yr 8 mo | SubstanceProductU-2296 |
| 8415345 | Jan 20, 2030 | in 3 yr 8 mo | SubstanceProductU-2032 |
| 7994185*PED | Jul 20, 2030 | in 4 yr 2 mo | |
| 8415345*PED | Jul 20, 2030 | in 4 yr 2 mo | |
| 8703781 | Oct 15, 2030 | in 4 yr 5 mo | SubstanceProductU-2296 |
| 8952018 | Oct 15, 2030 | in 4 yr 5 mo | U-2027 |
| 8952018*PED | Apr 15, 2031 | in 4 yr 11 mo | |
| 8703781*PED | Apr 15, 2031 | in 4 yr 11 mo | |
| 10869869 | Aug 30, 2033 | in 7 yr 4 mo | U-3185 |
| 10869869*PED | Feb 28, 2034 | in 7 yr 10 mo | |
| 11504333 | Jun 29, 2038 | in 12 yr 2 mo | Product |
| 11504333*PED | Dec 29, 2038 | in 12 yr 9 mo |
Dabrafenib mesylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
