FDA Orange Book
Is there a generic for Otezla XR?
Otezla XR contains apremilast. 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 Otezla XR (apremilast). The Orange Book shows its last listed patent expires May 27, 2042 and its last listed exclusivity ends January 20, 2027.
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Otezla XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 75MG | Marketed (Rx) | None | 0 | None |
NDA 210745, held by AMGEN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Otezla XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7427638 | February 16, 2028 | Drug substance, Drug product | None | 210745 |
| 10092541 | May 29, 2034 | Method of use | U-2659 | 210745 |
| 11752129 | May 27, 2042 | Drug product | U-4264 | 210745 |
| 11752129 | May 27, 2042 | Drug product | U-4265 | 210745 |
| 11752129 | May 27, 2042 | Drug product | U-4266 | 210745 |
| 12427136 | May 27, 2042 | Method of use | U-1858 | 210745 |
| 12427136 | May 27, 2042 | Method of use | U-4290 | 210745 |
| 12427136 | May 27, 2042 | Method of use | U-4291 | 210745 |
| 11969409 | May 27, 2042 | Drug product | None | 210745 |
Otezla XR exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE* | See the Orange Book exclusivity code list | July 19, 2026 | 210745 |
| M-299 | Miscellaneous | July 20, 2026 | 210745 |
| PED | Pediatric exclusivity | January 19, 2027 | 210745 |
| PED | Pediatric exclusivity | January 20, 2027 | 210745 |
Otezla XR NDC codes
Questions
Is there a generic for Otezla XR?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Otezla XR (apremilast). The Orange Book shows its last listed patent expires May 27, 2042 and its last listed exclusivity ends January 20, 2027.
What is the generic name for Otezla XR?
The active ingredient in Otezla XR is apremilast, per the FDA Orange Book.
When does the Otezla XR patent expire?
The last patent listed for Otezla XR in the Orange Book expires May 27, 2042. 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.