FDA Orange Book · active-ingredient family
Ponatinib hydrochloride
Ponatinib hydrochloride is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ICLUSIG · NDA 203469
1
Brand (NDA)
1
Generics (ANDA)
6
Listed patents
8
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ICLUSIGRLD×4 | TAKEDA PHARMS USA | NDA 203469 | — | Dec 18, 2020 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PONATINIB HYDROCHLORIDE×2 | APOTEX | ANDA 215893 | — | Jul 14, 2023 |
Marketing exclusivity (8)
- 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
- 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
- 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
- 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 (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9029533 | Dec 22, 2026 | in 6 mo | U-1701 |
| 8114874 | Jan 24, 2027 | in 7 mo | SubstanceProduct |
| 9493470 | Dec 12, 2033 | in 7 yr 7 mo | SubstanceProductU-1948 |
| 11384086 | Dec 12, 2033 | in 7 yr 7 mo | SubstanceProductU-1948 |
| 11192897 | Dec 12, 2033 | in 7 yr 7 mo | SubstanceU-1700 |
| 11192895 | Dec 12, 2033 | in 7 yr 7 mo | U-1700 |
Ponatinib hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
