FDA Orange Book
Is there a generic for Austedo XR?
Austedo XR contains deutetrabenazine. 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 Austedo XR (deutetrabenazine). The Orange Book shows its last listed patent expires June 10, 2041.
Run it in Rivvi
Map Austedo XR 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.
Austedo XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 12MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 18MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 24MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 30MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 36MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 42MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 48MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 6MG | Marketed (Rx) | None | 0 | None |
NDA 216354, held by TEVA NEUROSCIENCE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Austedo XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8524733 | April 3, 2031 | Drug substance, Drug product | None | 216354 |
| 8524733*PED | October 3, 2031 | Method of use | None | 216354 |
| 9550780 | September 18, 2033 | Drug substance, Drug product | U-1995 | 216354 |
| 9550780 | September 18, 2033 | Drug substance, Drug product | U-3055 | 216354 |
| 9550780*PED | March 18, 2034 | Method of use | None | 216354 |
| 12016858 | March 7, 2036 | Method of use | U-1995 | 216354 |
| 12016858 | March 7, 2036 | Method of use | U-3055 | 216354 |
| 10959996 | March 7, 2036 | Method of use | U-3055 | 216354 |
| 11564917 | March 7, 2036 | Method of use | U-1995 | 216354 |
| 11446291 | March 7, 2036 | Method of use | U-1995 | 216354 |
| 11357772 | March 7, 2036 | Method of use | U-1995 | 216354 |
| 11357772 | March 7, 2036 | Method of use | U-3055 | 216354 |
| 11648244 | March 7, 2036 | Method of use | U-1995 | 216354 |
| 11648244*PED | September 7, 2036 | Method of use | None | 216354 |
| 12016858*PED | September 7, 2036 | Method of use | None | 216354 |
| 10959996*PED | September 7, 2036 | Method of use | None | 216354 |
| 11564917*PED | September 7, 2036 | Method of use | None | 216354 |
| 11446291*PED | September 7, 2036 | Method of use | None | 216354 |
| 11357772*PED | September 7, 2036 | Method of use | None | 216354 |
| 11179386 | March 15, 2038 | Drug product | U-1995 | 216354 |
| 11179386 | March 15, 2038 | Drug product | U-3055 | 216354 |
| 11813232 | March 15, 2038 | Drug product | None | 216354 |
| 11813232*PED | September 15, 2038 | Method of use | None | 216354 |
| 11179386*PED | September 15, 2038 | Method of use | None | 216354 |
| 11311488 | June 10, 2041 | Drug product | U-1995 | 216354 |
| 11311488 | June 10, 2041 | Drug product | U-3055 | 216354 |
| 12599598 | June 10, 2041 | Method of use | U-3055 | 216354 |
| 12599598 | June 10, 2041 | Method of use | U-1995 | 216354 |
| 12589075 | June 10, 2041 | Method of use | U-3055 | 216354 |
| 12589075 | June 10, 2041 | Method of use | U-1995 | 216354 |
Austedo XR NDC codes
Questions
Is there a generic for Austedo XR?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Austedo XR (deutetrabenazine). The Orange Book shows its last listed patent expires June 10, 2041.
What is the generic name for Austedo XR?
The active ingredient in Austedo XR is deutetrabenazine, per the FDA Orange Book.
When does the Austedo XR patent expire?
The last patent listed for Austedo XR in the Orange Book expires June 10, 2041. 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.