FDA Orange Book
Is there a generic for Austedo?
Austedo 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 (deutetrabenazine). The Orange Book shows its last listed patent expires September 15, 2038.
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Austedo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 12MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 6MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 9MG | Marketed (Rx) | None | 0 | None |
NDA 208082, held by TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Austedo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8524733 | April 3, 2031 | Drug substance, Drug product | None | 208082 |
| 8524733*PED | October 3, 2031 | Method of use | None | 208082 |
| 9550780 | September 18, 2033 | Drug substance, Drug product | U-1995 | 208082 |
| 9550780 | September 18, 2033 | Drug substance, Drug product | U-3055 | 208082 |
| 9233959 | September 18, 2033 | Drug product | None | 208082 |
| 9296739 | September 18, 2033 | Drug product | None | 208082 |
| 11666566 | September 18, 2033 | Drug product | None | 208082 |
| 9814708 | September 18, 2033 | Drug product | None | 208082 |
| 9233959*PED | March 18, 2034 | Method of use | None | 208082 |
| 9296739*PED | March 18, 2034 | Method of use | None | 208082 |
| 9550780*PED | March 18, 2034 | Method of use | None | 208082 |
| 9814708*PED | March 18, 2034 | Method of use | None | 208082 |
| 11666566*PED | March 18, 2034 | Method of use | None | 208082 |
| 10959996 | March 7, 2036 | Method of use | U-3055 | 208082 |
| 11564917 | March 7, 2036 | Method of use | U-1995 | 208082 |
| 11357772 | March 7, 2036 | Method of use | U-1995 | 208082 |
| 11357772 | March 7, 2036 | Method of use | U-3055 | 208082 |
| 12016858 | March 7, 2036 | Method of use | U-1995 | 208082 |
| 12016858 | March 7, 2036 | Method of use | U-3055 | 208082 |
| 11648244 | March 7, 2036 | Method of use | U-1995 | 208082 |
| 11446291 | March 7, 2036 | Method of use | U-1995 | 208082 |
| 10959996*PED | September 7, 2036 | Method of use | None | 208082 |
| 11564917*PED | September 7, 2036 | Method of use | None | 208082 |
| 11648244*PED | September 7, 2036 | Method of use | None | 208082 |
| 11446291*PED | September 7, 2036 | Method of use | None | 208082 |
| 11357772*PED | September 7, 2036 | Method of use | None | 208082 |
| 12016858*PED | September 7, 2036 | Method of use | None | 208082 |
| 11179386 | March 15, 2038 | Drug product | U-1995 | 208082 |
| 11179386 | March 15, 2038 | Drug product | U-3055 | 208082 |
| 11813232 | March 15, 2038 | Drug product | None | 208082 |
| 11813232*PED | September 15, 2038 | Method of use | None | 208082 |
| 11179386*PED | September 15, 2038 | Method of use | None | 208082 |
Austedo NDC codes
Questions
Is there a generic for Austedo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Austedo (deutetrabenazine). The Orange Book shows its last listed patent expires September 15, 2038.
What is the generic name for Austedo?
The active ingredient in Austedo is deutetrabenazine, per the FDA Orange Book.
When does the Austedo patent expire?
The last patent listed for Austedo in the Orange Book expires September 15, 2038. 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.