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

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Addressing Involuntary Movements in Tardive Dyskinesia NCT02291861	Phase 3	Completed	Auspex Pharmaceuticals, Inc.	298	2014-10-31 → 2016-08-19

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

Medicare Part D Spending

CMS annual spending data for Austedo (2023)

Total Spending

$1.1B

Total Claims

166,182

Beneficiaries

18,283

Avg Cost/Unit

$103.61

Spending Trend

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

YoY Change:+6.5%

5yr CAGR:+6.8%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain5 active DMFs

5 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

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)

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