FDA Orange Book
Is there a generic for Copiktra?
Copiktra contains duvelisib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Copiktra (duvelisib). The Orange Book shows its last listed patent expires April 26, 2035.
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Copiktra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 15MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 25MG | Marketed (Rx) | None | 0 | None |
NDA 211155, held by SECURA BIO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Copiktra patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9216982 | January 5, 2029 | Method of use | U-2413 | 211155 |
| 9216982 | January 5, 2029 | Method of use | U-2412 | 211155 |
| 9840505 | January 10, 2032 | Method of use | U-2413 | 211155 |
| 9840505 | January 10, 2032 | Method of use | U-2412 | 211155 |
| 11312718 | January 10, 2032 | Drug product | None | 211155 |
| RE46621 | May 17, 2032 | Drug substance, Drug product | None | 211155 |
| 8193182 | September 24, 2032 | Drug substance | None | 211155 |
| 12213983 | April 26, 2035 | Method of use | U-2412 | 211155 |
Copiktra NDC codes
Questions
Is there a generic for Copiktra?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Copiktra (duvelisib). The Orange Book shows its last listed patent expires April 26, 2035.
What is the generic name for Copiktra?
The active ingredient in Copiktra is duvelisib, per the FDA Orange Book.
When does the Copiktra patent expire?
The last patent listed for Copiktra in the Orange Book expires April 26, 2035. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.