Orange Book product · Brand (NDA)
XOSPATA
GILTERITINIB FUMARATE
At a glance
Nov 28, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 28, 2018
7 yr 8 mo ago
Today
Patent 9487491 expires
Listed method-of-use patent (U-2456) expiration.
Jul 28, 2030
in 4 yr 2 mo
Patent 8969336 expires
Listed drug substance patent expiration.
Nov 28, 2032
in 6 yr 6 mo
Patent 10786500 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 11938130 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 11938131 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 11938132 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 11938133 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 11944620 expires
Listed drug product patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Pharmaceutical detail
Active ingredient
GILTERITINIB FUMARATE
Strength
EQ 40MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 211349
Product number
001
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.
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 |
| 10786500 | Jul 01, 2036 | in 10 yr 2 mo | Product |
| 11938130 | 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 |
| 11938133 | Jul 01, 2036 | in 10 yr 2 mo | Product |
| 11944620 | Jul 01, 2036 | in 10 yr 2 mo | Product |
