Orange Book product · Brand (NDA)
ICLUSIG
PONATINIB HYDROCHLORIDE
At a glance
Dec 18, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
17
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 18, 2020
5 yr 7 mo ago
Today
Patent 9029533 expires
Listed method-of-use patent (U-1701) expiration.
Dec 22, 2026
in 6 mo
Patent 9029533 expires
Listed method-of-use patent (U-1700) expiration.
Dec 22, 2026
in 6 mo
Patent 9029533 expires
Listed method-of-use patent (U-836) expiration.
Dec 22, 2026
in 6 mo
Patent 9029533 expires
Listed method-of-use patent (U-1283) expiration.
Dec 22, 2026
in 6 mo
Patent 9029533 expires
Listed method-of-use patent (U-1699) expiration.
Dec 22, 2026
in 6 mo
Patent 8114874 expires
Listed drug substance patent expiration.
Jan 24, 2027
in 7 mo
Exclusivity ends · I-934
New indication exclusivity (3 years)
Mar 19, 2027
in 9 mo
Exclusivity ends · ODE-472
Orphan-drug exclusivity (7 years)
Mar 19, 2031
in 4 yr 10 mo
Patent 11192895 expires
Listed method-of-use patent (U-1700) expiration.
Dec 12, 2033
in 7 yr 7 mo
Patent 11192895 expires
Listed method-of-use patent (U-1701) expiration.
Dec 12, 2033
in 7 yr 7 mo
Patent 11192895 expires
Listed method-of-use patent (U-1948) expiration.
Dec 12, 2033
in 7 yr 7 mo
Patent 11192897 expires
Listed drug substance patent expiration.
Dec 12, 2033
in 7 yr 7 mo
Patent 11192897 expires
Listed drug substance patent expiration.
Dec 12, 2033
in 7 yr 7 mo
Patent 11192897 expires
Listed drug substance patent expiration.
Dec 12, 2033
in 7 yr 7 mo
Patent 11384086 expires
Listed drug substance patent expiration.
Dec 12, 2033
in 7 yr 7 mo
Patent 11384086 expires
Listed drug substance patent expiration.
Dec 12, 2033
in 7 yr 7 mo
Patent 11384086 expires
Listed drug substance patent expiration.
Dec 12, 2033
in 7 yr 7 mo
Patent 9493470 expires
Listed drug substance patent expiration.
Dec 12, 2033
in 7 yr 7 mo
Patent 9493470 expires
Listed drug substance patent expiration.
Dec 12, 2033
in 7 yr 7 mo
Pharmaceutical detail
Active ingredient
PONATINIB HYDROCHLORIDE
Strength
EQ 10MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 203469
Product number
004
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 (2)
- I-934New indication exclusivity (3 years)
Mar 19, 2027
in 9 mo
- ODE-472Orphan-drug exclusivity (7 years)
Mar 19, 2031
in 4 yr 10 mo
Listed patents (17)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9029533 | Dec 22, 2026 | in 6 mo | U-1701 |
| 9029533 | Dec 22, 2026 | in 6 mo | U-1700 |
| 9029533 | Dec 22, 2026 | in 6 mo | U-836 |
| 9029533 | Dec 22, 2026 | in 6 mo | U-1283 |
| 9029533 | Dec 22, 2026 | in 6 mo | U-1699 |
| 8114874 | Jan 24, 2027 | in 7 mo | SubstanceProduct |
| 11192895 | Dec 12, 2033 | in 7 yr 7 mo | U-1700 |
| 11192895 | Dec 12, 2033 | in 7 yr 7 mo | U-1701 |
| 11192895 | Dec 12, 2033 | in 7 yr 7 mo | U-1948 |
| 11192897 | Dec 12, 2033 | in 7 yr 7 mo | SubstanceU-1700 |
| 11192897 | Dec 12, 2033 | in 7 yr 7 mo | SubstanceU-1701 |
| 11192897 | Dec 12, 2033 | in 7 yr 7 mo | SubstanceU-1948 |
| 11384086 | Dec 12, 2033 | in 7 yr 7 mo | SubstanceProductU-1948 |
| 11384086 | Dec 12, 2033 | in 7 yr 7 mo | SubstanceProductU-1701 |
| 11384086 | Dec 12, 2033 | in 7 yr 7 mo | SubstanceProductU-1700 |
| 9493470 | Dec 12, 2033 | in 7 yr 7 mo | SubstanceProductU-1948 |
| 9493470 | Dec 12, 2033 | in 7 yr 7 mo | SubstanceProductU-1700 |
