FDA Orange Book
Is there a generic for Xtampza ER?
Xtampza ER contains oxycodone. 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 Xtampza ER (oxycodone). The Orange Book shows its last listed patent expires September 2, 2036.
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Xtampza ER products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 13.5MG | Marketed (Rx) | None | 0 | None |
| capsule, extended release, oral | 18MG | Marketed (Rx) | None | 0 | None |
| capsule, extended release, oral | 27MG | Marketed (Rx) | None | 0 | None |
| capsule, extended release, oral | 36MG | Marketed (Rx) | None | 0 | None |
| capsule, extended release, oral | 9MG | Marketed (Rx) | None | 0 | None |
NDA 208090, held by COLLEGIUM PHARMACEUTICAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xtampza ER patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7771707 | October 9, 2028 | Drug product | None | 208090 |
| 10004729 | December 10, 2030 | Drug product | U-1556 | 208090 |
| 9682075 | December 10, 2030 | Drug product | U-1556 | 208090 |
| 10668060 | December 10, 2030 | Drug product | U-1556 | 208090 |
| 10188644 | September 2, 2036 | Drug product | U-1556 | 208090 |
| 10646485 | September 2, 2036 | Drug product | U-1556 | 208090 |
| 9968598 | September 2, 2036 | Drug product | U-1556 | 208090 |
| 9737530 | September 2, 2036 | Drug product | U-1556 | 208090 |
Xtampza ER NDC codes
Questions
Is there a generic for Xtampza ER?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xtampza ER (oxycodone). The Orange Book shows its last listed patent expires September 2, 2036.
What is the generic name for Xtampza ER?
The active ingredient in Xtampza ER is oxycodone, per the FDA Orange Book.
When does the Xtampza ER patent expire?
The last patent listed for Xtampza ER in the Orange Book expires September 2, 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.