FDA Orange Book · active-ingredient family
Deutetrabenazine
Deutetrabenazine: 2 brands, 1 generic; first approved Apr 03, 2017; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 1 ANDA application approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
1
Listed patents
31
Next patent expiry
Apr 03, 2031
in 4 yr 8 mo
Brand (NDA) products
Originator applications
- AUSTEDO XRRLDTEVANDA 21635420238 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG TABLET, EXTENDED RELEASE ORAL Rx — 12MG TABLET, EXTENDED RELEASE ORAL Rx — 24MG TABLET, EXTENDED RELEASE ORAL Rx — 30MG TABLET, EXTENDED RELEASE ORAL Rx — 36MG TABLET, EXTENDED RELEASE ORAL Rx — 42MG TABLET, EXTENDED RELEASE ORAL Rx — 48MG TABLET, EXTENDED RELEASE ORAL Rx — 18MG TABLET, EXTENDED RELEASE ORAL Rx — - AUSTEDORLDTEVA BRANDED PHARMNDA 20808220173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG TABLET ORAL Rx — 9MG TABLET ORAL Rx — 12MG TABLET ORAL Rx —
Generic (ANDA) products (1)
Abbreviated applications
- DEUTETRABENAZINEAUROBINDO PHARMA LTDANDA 21597120243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG TABLET ORAL Discontinued — 9MG TABLET ORAL Discontinued — 12MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8524733 | in 4 yr 8 mo | SubstanceProduct | |
| 8524733*PED | in 5 yr 2 mo | ||
| 9550780 | in 7 yr 2 mo | SubstanceProductU-1995 | |
| 9233959 | in 7 yr 2 mo | Product | |
| 9296739 | in 7 yr 2 mo | Product | |
| 11666566 | in 7 yr 2 mo | Product | |
| 9814708 | in 7 yr 2 mo | Product | |
| 9550780*PED | in 7 yr 8 mo | ||
| 9233959*PED | in 7 yr 8 mo | ||
| 9296739*PED | in 7 yr 8 mo | ||
| 9814708*PED | in 7 yr 8 mo | ||
| 11666566*PED | in 7 yr 8 mo | ||
| 12016858 | in 9 yr 8 mo | U-1995 | |
| 10959996 | in 9 yr 8 mo | U-3055 | |
| 11564917 | in 9 yr 8 mo | U-1995 | |
| 11446291 | in 9 yr 8 mo | U-1995 | |
| 11357772 | in 9 yr 8 mo | U-1995 | |
| 11648244 | in 9 yr 8 mo | U-1995 | |
| 11648244*PED | in 10 yr 2 mo | ||
| 12016858*PED | in 10 yr 2 mo | ||
| 10959996*PED | in 10 yr 2 mo | ||
| 11564917*PED | in 10 yr 2 mo | ||
| 11446291*PED | in 10 yr 2 mo | ||
| 11357772*PED | in 10 yr 2 mo | ||
| 11179386 | in 11 yr 9 mo | ProductU-1995 | |
| 11813232 | in 11 yr 9 mo | Product | |
| 11813232*PED | in 12 yr 3 mo | ||
| 11179386*PED | in 12 yr 3 mo | ||
| 11311488 | in 15 yr | ProductU-1995 | |
| 12599598 | in 15 yr | U-3055 | |
| 12589075 | in 15 yr | U-3055 |
Approval history
FDA approval span
First approval
9 yr 6 mo ago
Most recent approval
1 yr 8 mo ago
Approvals span 2017–2024 across 3 FDA applications.
Brand (NDA) 267%
Generic (ANDA) 133%
Deutetrabenazine: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
