FDA Orange Book · active-ingredient family
Avutometinib potassium; defactinib hydrochloride
Avutometinib potassium; defactinib hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) · NDA 219616
1
Brand (NDA)
0
Generics (ANDA)
7
Listed patents
2
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)RLD | VERASTEM INC | NDA 219616 | — | May 08, 2025 |
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
May 08, 2030
in 3 yr 11 mo
- ODE-525Orphan-drug exclusivity (7 years)
May 08, 2032
in 6 yr
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7897792 | Feb 09, 2027 | in 8 mo | SubstanceProduct |
| 8247411 | Apr 17, 2028 | in 1 yr 10 mo | SubstanceProduct |
| 7928109 | Aug 21, 2029 | in 3 yr 3 mo | SubstanceProduct |
| 11400090 | Oct 29, 2038 | in 12 yr 7 mo | U-4196 |
| 11517573 | Sep 11, 2040 | in 14 yr 5 mo | U-4196 |
| 11873296 | Dec 29, 2042 | in 16 yr 9 mo | ProductU-4196 |
| 12509450 | Dec 29, 2042 | in 16 yr 9 mo | Product |
Avutometinib potassium; defactinib hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
