FDA Orange Book · active-ingredient family
Encorafenib
Encorafenib is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:BRAFTOVI · NDA 210496
1
Brand (NDA)
0
Generics (ANDA)
13
Listed patents
6
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BRAFTOVIRLD×2 | ARRAY BIOPHARMA INC | NDA 210496 | — | Jun 27, 2018 |
Marketing exclusivity (6)
- I-928New indication exclusivity (3 years)
Oct 11, 2026
in 4 mo
- I-957New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
- ODE-445Orphan-drug exclusivity (7 years)
Oct 11, 2030
in 4 yr 5 mo
- I-928New indication exclusivity (3 years)
Oct 11, 2026
in 4 mo
- I-957New indication exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
- ODE-445Orphan-drug exclusivity (7 years)
Oct 11, 2030
in 4 yr 5 mo
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8946250 | Jul 23, 2029 | in 3 yr 2 mo | SubstanceProduct |
| 8541575 | Feb 26, 2030 | in 3 yr 9 mo | SubstanceProductU-2335 |
| RE49556 | Feb 27, 2030 | in 3 yr 9 mo | SubstanceProduct |
| 9850230 | Aug 27, 2030 | in 4 yr 3 mo | U-2334 |
| 10005761 | Aug 27, 2030 | in 4 yr 3 mo | U-2335 |
| 9850229 | Aug 27, 2030 | in 4 yr 3 mo | U-2337 |
| 9593099 | Aug 27, 2030 | in 4 yr 3 mo | Substance |
| 9593100 | Aug 27, 2030 | in 4 yr 3 mo | Product |
| 9314464 | Jul 04, 2031 | in 5 yr 1 mo | U-2336 |
| 9763941 | Nov 21, 2032 | in 6 yr 6 mo | U-2335 |
| 9387208 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 10258622 | Nov 21, 2032 | in 6 yr 6 mo | U-4439 |
| 9474754 | Aug 05, 2033 | in 7 yr 3 mo | U-4440 |
Encorafenib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
