Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

12 trials from ClinicalTrials.gov, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Reducing Involuntary Movements in Participants With Tardive Dyskinesia NCT02198794	Phase 3	Completed	Auspex Pharmaceuticals, Inc.	343	2014-10-20 → 2020-12-14
Alternatives for Reducing Chorea in Huntington Disease NCT01897896	Phase 3	Completed	Auspex Pharmaceuticals, Inc.	119	2013-11-12 → 2017-08-21
A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents NCT03813238	Phase 3	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	63	2019-08-06 → 2022-07-21
An Open-label Study to Define the Safety, Tolerability and Clinical Activity of Deutetrabenazine (AUstedo) in Adult Study Subjects With DYsTonia NCT04173260	Phase 1/2	Completed	University of Pennsylvania	15	2021-04-29 → 2024-08-31
Aim to Reduce Movements in Tardive Dyskinesia NCT02195700	Phase 2/3	Completed	Auspex Pharmaceuticals, Inc.	117	2014-06 → 2015-05
Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents NCT03452943	Phase 2/3	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	119	2018-02-05 → 2019-11-12
First Time Use of SD-809 in Huntington Disease NCT01795859	Phase 3	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	90	2013-08-05 → 2014-12-05
A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS)NCT03571256	Phase 3	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	158	2018-05-31 → 2019-12-09
Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents NCT03567291	Phase 3	Terminated	Teva Branded Pharmaceutical Products R&D, Inc.	228	2018-05-25 → 2020-05-15
A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy NCT04200352	Phase 3	Terminated	Teva Branded Pharmaceutical Products R&D, Inc.	44	2020-02-04 → 2023-02-14

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$125.45

per ea

Lowest NADAC/Unit

$83.25

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
68546017260AUSTEDO 12 MG TABLET	$125.45	EA	Brand	—	2026-06-17
68546017160AUSTEDO 9 MG TABLET	$94.16	EA	Brand	—	2026-06-17
68546017060AUSTEDO 6 MG TABLET	$83.25	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$3637.97

Highest Price

$6417.81

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
68546-0170-60AUSTEDO 6MG TAB	$4501.20	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
68546-0170-60AUSTEDO 6MG TAB	$3637.97	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
68546-0171-60AUSTEDO 9MG TAB	$5063.95	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
68546-0171-60AUSTEDO 9MG TAB	$4094.00	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
68546-0172-60AUSTEDO 12MG TAB	$6417.81	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
68546-0172-60AUSTEDO 12MG TAB	$5452.82	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Austedo (2024)

Total Spending

$1.1B

Total Claims

162,212

Beneficiaries

18,418

Avg Cost/Unit

$103.14

Spending Trend

$339.7M(2019)→$530.5M(2020)→$666.0M(2021)→$890.4M(2022)→$1.1B(2023)→$1.1B(2024)

YoY Change:-0.5%

5yr CAGR:+5.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain6 active DMFs

6 active API suppliers hold Drug Master Files for this ingredient.

MAITHRI DRUGS PRIVATE LTDDEUTETRABENAZINE

DMF 351582020

HETERO DRUGS LTDDEUTETRABENAZINE

DMF 351972020

APITORIA PHARMA PRIVATE LTDDEUTETRABENAZINE

DMF 352472020

LUPIN MANUFACTURING SOLUTIONS LTDDEUTETRABENAZINE

DMF 353812020

FARMHISPANIA SADEUTETRABENAZINE

DMF 373412022

MSN LIFE SCIENCES PRIVATE LTDDEUTETRABENAZINE

DMF 437192026

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Jun 2, 2025	SUPPL -18	View Letter (PDF)
Nov 29, 2024	SUPPL -17	View Letter (PDF)
Nov 29, 2024	SUPPL -16	View Letter (PDF)
Sep 29, 2023	SUPPL -14	View Letter (PDF)
May 5, 2022	SUPPL -11	View Letter (PDF)
Jun 25, 2021	SUPPL -9	View Letter (PDF)
Feb 9, 2021	SUPPL -8	View Letter (PDF)
Dec 3, 2020	SUPPL -7	View Letter (PDF)
Jul 16, 2019	SUPPL -4	View Letter (PDF)
Jun 14, 2018	SUPPL -2	View Letter (PDF)
Apr 3, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 6MG

RLD

14 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 3, 2017

Patents (14) · 12 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8524733	Apr 3, 2031PED: Oct 3, 2031	PED	Yes	Yes	—	—
9233959	Sep 18, 2033PED: Mar 18, 2034	PED	—	Yes	—	—
9296739	Sep 18, 2033PED: Mar 18, 2034	PED	—	Yes	—	—
9550780	Sep 18, 2033PED: Mar 18, 2034	PED	Yes	Yes		—
9814708	Sep 18, 2033PED: Mar 18, 2034	PED	—	Yes	—	—
10959996	Mar 7, 2036PED: Sep 7, 2036	PED	—	—		—
11179386	Mar 15, 2038PED: Sep 15, 2038	PED	—	Yes		—
11357772	Mar 7, 2036PED: Sep 7, 2036	PED	—	—		—
11446291	Mar 7, 2036PED: Sep 7, 2036	PED	—	—		—
11564917	Mar 7, 2036PED: Sep 7, 2036	PED	—	—		—
11648244	Mar 7, 2036PED: Sep 7, 2036	PED	—	—		—
11666566	Sep 18, 2033PED: Mar 18, 2034	PED	—	Yes	—	—
11813232	Mar 15, 2038PED: Sep 15, 2038	PED	—	Yes	—	—
12016858	Mar 7, 2036PED: Sep 7, 2036	PED	—	—		—

#002 — 9MG

RLD

14 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 3, 2017

#003 — 12MG

RLD

14 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 3, 2017