FDA Orange Book · active-ingredient family
Ceritinib
Ceritinib is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ZYKADIA · NDA 211225
2
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZYKADIARLD | NOVARTIS | NDA 211225 | — | Mar 18, 2019 | |
| ZYKADIARLD | NOVARTIS | NDA 205755 | — | Apr 29, 2014 |
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7893074 | Apr 25, 2026 | 2 mo ago | SubstanceProduct |
| 8377921 | Nov 20, 2027 | in 1 yr 5 mo | U-1179 |
| 8399450 | Nov 20, 2027 | in 1 yr 5 mo | SubstanceProduct |
| 7964592 | Apr 29, 2028 | in 1 yr 11 mo | SubstanceProduct |
| 8039479 | Jun 29, 2030 | in 4 yr 1 mo | SubstanceProduct |
| 9309229 | Jan 18, 2032 | in 5 yr 8 mo | SubstanceProduct |
| 8703787 | Feb 02, 2032 | in 5 yr 8 mo | U-1179 |
| 12357630 | Dec 13, 2037 | in 11 yr 8 mo | U-3096 |
Ceritinib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
