FDA Orange Book · active-ingredient family
Dacomitinib
Dacomitinib is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:VIZIMPRO · NDA 211288
1
Brand (NDA)
0
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VIZIMPRORLD×3 | PFIZER | NDA 211288 | — | Sep 27, 2018 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10603314 | Feb 02, 2026 | 5 mo ago | U-3337 |
| 10596162 | Feb 02, 2026 | 5 mo ago | U-3338 |
| 7772243 | Sep 27, 2032 | in 6 yr 4 mo | SubstanceProduct |
Dacomitinib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
