FDA Orange Book · active-ingredient family
Afatinib dimaleate
Afatinib dimaleate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:GILOTRIF · NDA 201292
1
Brand (NDA)
0
Generics (ANDA)
10
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GILOTRIFRLD×3 | BOEHRINGER INGELHEIM | NDA 201292 | — | Jul 12, 2013 |
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 |
Afatinib dimaleate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
