Orange Book product · Brand (NDA)
TURALIO
PEXIDARTINIB HYDROCHLORIDE
At a glance
Oct 14, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
12
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 14, 2022
3 yr 9 mo ago
Today
Exclusivity ends · ODE*
FDA marketing exclusivity
Aug 02, 2026
in 1 mo
Patent 8404700 expires
Listed drug substance patent expiration.
Nov 21, 2027
in 1 yr 5 mo
Patent 8722702 expires
Listed drug substance patent expiration.
Nov 21, 2027
in 1 yr 5 mo
Patent 9169250 expires
Listed drug substance patent expiration.
Nov 21, 2027
in 1 yr 5 mo
Patent 8461169 expires
Listed method-of-use patent (U-2606) expiration.
Apr 19, 2028
in 1 yr 10 mo
Patent 7893075 expires
Listed drug substance patent expiration.
May 04, 2033
in 7 yr
Patent 9358235 expires
Listed method-of-use patent (U-2606) expiration.
Jun 08, 2033
in 7 yr 1 mo
Patent 10189833 expires
Listed method-of-use patent (U-2606) expiration.
May 05, 2036
in 10 yr
Patent 10730876 expires
Listed drug substance patent expiration.
May 05, 2036
in 10 yr
Patent 9802932 expires
Listed drug substance patent expiration.
May 05, 2036
in 10 yr
Patent 10435404 expires
Listed drug product patent expiration.
Jul 24, 2038
in 12 yr 3 mo
Patent 10941142 expires
Listed drug product patent expiration.
Jul 24, 2038
in 12 yr 3 mo
Patent 10961240 expires
Listed method-of-use patent (U-2606) expiration.
Jul 24, 2038
in 12 yr 3 mo
Pharmaceutical detail
Active ingredient
PEXIDARTINIB HYDROCHLORIDE
Strength
EQ 125MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 211810
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- ODE*FDA marketing exclusivity
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 |
| 10435404 | Jul 24, 2038 | in 12 yr 3 mo | Product |
| 10941142 | Jul 24, 2038 | in 12 yr 3 mo | Product |
| 10961240 | Jul 24, 2038 | in 12 yr 3 mo | U-2606 |
