FDA Orange Book · active-ingredient family
Gilteritinib fumarate
Gilteritinib fumarate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:XOSPATA · NDA 211349
1
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XOSPATARLD | ASTELLAS | NDA 211349 | — | Nov 28, 2018 |
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9487491 | Jul 28, 2030 | in 4 yr 2 mo | U-2456 |
| 8969336 | Nov 28, 2032 | in 6 yr 6 mo | SubstanceProduct |
| 11938133 | Jul 01, 2036 | in 10 yr 2 mo | Product |
| 11944620 | Jul 01, 2036 | in 10 yr 2 mo | Product |
| 11938130 | Jul 01, 2036 | in 10 yr 2 mo | Product |
| 10786500 | Jul 01, 2036 | in 10 yr 2 mo | Product |
| 11938131 | Jul 01, 2036 | in 10 yr 2 mo | Product |
| 11938132 | Jul 01, 2036 | in 10 yr 2 mo | Product |
Gilteritinib fumarate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
