FDA Orange Book · active-ingredient family
Pexidartinib hydrochloride
Pexidartinib hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:TURALIO · NDA 211810
1
Brand (NDA)
0
Generics (ANDA)
12
Listed patents
2
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TURALIORLD×2 | DAIICHI SANKYO INC | NDA 211810 | — | Oct 14, 2022 |
Marketing exclusivity (2)
- ODE*FDA marketing exclusivity
Aug 02, 2026
in 1 mo
- ODE-250Orphan-drug exclusivity (7 years)
Aug 02, 2026
in 1 mo
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8404700 | Nov 21, 2027 | in 1 yr 5 mo | Substance |
| 8722702 | Nov 21, 2027 | in 1 yr 5 mo | Substance |
| 9169250 | Nov 21, 2027 | in 1 yr 5 mo | Substance |
| 8461169 | Apr 19, 2028 | in 1 yr 10 mo | U-2606 |
| 7893075 | May 04, 2033 | in 7 yr | Substance |
| 9358235 | Jun 08, 2033 | in 7 yr 1 mo | U-2606 |
| 10189833 | May 05, 2036 | in 10 yr | U-2606 |
| 10730876 | May 05, 2036 | in 10 yr | Substance |
| 9802932 | May 05, 2036 | in 10 yr | Substance |
| 10961240 | Jul 24, 2038 | in 12 yr 3 mo | U-2606 |
| 10941142 | Jul 24, 2038 | in 12 yr 3 mo | Product |
| 10435404 | Jul 24, 2038 | in 12 yr 3 mo | Product |
Pexidartinib hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
