FDA Orange Book · active-ingredient family
Duvelisib
Duvelisib is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:COPIKTRA · NDA 211155
1
Brand (NDA)
0
Generics (ANDA)
6
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COPIKTRARLD×2 | SECURA | NDA 211155 | — | Sep 24, 2018 |
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9216982 | Jan 05, 2029 | in 2 yr 7 mo | U-2413 |
| 9840505 | Jan 10, 2032 | in 5 yr 8 mo | U-2413 |
| 11312718 | Jan 10, 2032 | in 5 yr 8 mo | Product |
| RE46621 | May 17, 2032 | in 6 yr | SubstanceProduct |
| 8193182 | Sep 24, 2032 | in 6 yr 4 mo | Substance |
| 12213983 | Apr 26, 2035 | in 9 yr | U-2412 |
Duvelisib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
