FDA Orange Book
Is there a generic for Cibinqo?
Cibinqo contains abrocitinib. 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 Cibinqo (abrocitinib). The Orange Book shows its last listed patent expires January 14, 2036 and its last listed exclusivity ends January 14, 2027.
Run it in Rivvi
Map Cibinqo and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Cibinqo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 200MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 50MG | Marketed (Rx) | None | 0 | None |
NDA 213871, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Cibinqo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9549929 | February 19, 2034 | Method of use | U-3195 | 213871 |
| 9545405 | February 19, 2034 | Drug substance, Drug product | None | 213871 |
| 9035074 | January 14, 2036 | Drug substance, Drug product | None | 213871 |
Cibinqo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | February 9, 2026 | 213871 |
| NCE | New chemical entity | January 14, 2027 | 213871 |
Cibinqo NDC codes
Questions
Is there a generic for Cibinqo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cibinqo (abrocitinib). The Orange Book shows its last listed patent expires January 14, 2036 and its last listed exclusivity ends January 14, 2027.
What is the generic name for Cibinqo?
The active ingredient in Cibinqo is abrocitinib, per the FDA Orange Book.
When does the Cibinqo patent expire?
The last patent listed for Cibinqo in the Orange Book expires January 14, 2036. 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.