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TETRABENAZINE

ANDA

TETRABENAZINE | A204574 | HETERO LABS LTD UNIT V

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: XENAZINE(TE code: AB)

Medicare Part D Spending

CMS annual spending data for Tetrabenazine (2023)

Total Spending

$58.9M

Total Claims

25,914

Beneficiaries

3,523

Avg Cost/Unit

$31.31

Spending Trend

$78.1M(2019)→$76.8M(2020)→$65.5M(2021)→$65.0M(2022)→$58.9M(2023)

YoY Change:-7.2%

5yr CAGR:-8.1%

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

API Supply Chain12 active DMFs

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

CORDEN PHARMA CHENOVETETRABENAZINE

DMF 166832003

CHEMWERTH INCTETRABENAZINE(NON-STERILE BULK DRUG SUBSTANCE)

DMF 249462011

HETERO DRUGS LTDTETRABENAZINE

DMF 261132012

CENTAUR PHARMACEUTICALS PVT LTDTETRABENAZINE

DMF 263082012

APOTEX PHARMACHEM INDIA PVT LTDTETRABENAZINE

DMF 271352013

MATRIX PHARMACORP PRIVATE LTDTETRABENAZINE

DMF 271472013

SUN PHARMACEUTICAL INDUSTRIES LTDTETRABENAZINE

DMF 271862013

MATRIX PHARMACORP PRIVATE LTDTETRABENAZINE

DMF 281942014

ROLABO OUTSOURCING SLTETRABENAZINE

DMF 298282015

PIRAMAL PHARMA LTDTETRABENAZINE

DMF 324502018

INKE SATETRABENAZINE

DMF 372182022

AGNO PHARMATETRABENAZINE

DMF 401142024

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 5, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 12.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 3, 2016

No patent or exclusivity listings for this strength.

#002 — 25MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 3, 2016