Orange Book product · Brand (NDA)
GILOTRIF
AFATINIB DIMALEATE
At a glance
Jul 12, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 12, 2013
13 yr 2 mo ago
Patent RE43431 expires
Listed drug substance patent expiration.
Jan 13, 2026
5 mo ago
Today
Patent RE43431*PED expires
Listed listed patent expiration.
Jul 13, 2026
in 24 d
Patent 9539258 expires
Listed method-of-use patent (U-1950) expiration.
Nov 09, 2026
in 5 mo
Patent 9539258*PED expires
Listed listed patent expiration.
May 09, 2027
in 11 mo
Patent 8426586 expires
Listed drug substance patent expiration.
Oct 10, 2029
in 3 yr 4 mo
Patent 8545884 expires
Listed drug product patent expiration.
Dec 19, 2029
in 3 yr 7 mo
Patent 8426586*PED expires
Listed listed patent expiration.
Apr 10, 2030
in 3 yr 10 mo
Patent 8545884*PED expires
Listed listed patent expiration.
Jun 19, 2030
in 4 yr 1 mo
Patent 10004743 expires
Listed drug product patent expiration.
Jul 05, 2030
in 4 yr 1 mo
Patent 10004743*PED expires
Listed listed patent expiration.
Jan 05, 2031
in 4 yr 7 mo
Pharmaceutical detail
Active ingredient
AFATINIB DIMALEATE
Strength
EQ 20MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 201292
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE43431 | Jan 13, 2026 | 5 mo ago | Substance |
| RE43431*PED | Jul 13, 2026 | in 24 d | |
| 9539258 | Nov 09, 2026 | in 5 mo | U-1950 |
| 9539258*PED | May 09, 2027 | in 11 mo | |
| 8426586 | Oct 10, 2029 | in 3 yr 4 mo | Substance |
| 8545884 | Dec 19, 2029 | in 3 yr 7 mo | Product |
| 8426586*PED | Apr 10, 2030 | in 3 yr 10 mo | |
| 8545884*PED | Jun 19, 2030 | in 4 yr 1 mo | |
| 10004743 | Jul 05, 2030 | in 4 yr 1 mo | Product |
| 10004743*PED | Jan 05, 2031 | in 4 yr 7 mo |

