Viewing data from:

XENAZINE

NDA

TETRABENAZINE | N021894 | BAUSCH HEALTH US LLC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Xenazine (2023)

Total Spending

$9.1M

Total Claims

222

Beneficiaries

Avg Cost/Unit

$310.56

Spending Trend

$30.1M(2019)→$22.4M(2020)→$15.0M(2021)→$10.9M(2022)→$9.1M(2023)

YoY Change:+15.4%

5yr CAGR:+12.9%

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

10 letters from Drugs@FDA

Date	Submission	Document
Sep 19, 2017	SUPPL -13	View Letter (PDF)
Aug 27, 2015	SUPPL -12	View Letter (PDF)
Jun 4, 2015	SUPPL -10	View Letter (PDF)
Aug 5, 2013	SUPPL -9	View Letter (PDF)
Aug 27, 2012	SUPPL -7	View Letter (PDF)
Jul 7, 2011	SUPPL -4	View Letter (PDF)
May 6, 2011	SUPPL -5	View Letter (PDF)
Jan 27, 2010	SUPPL -2	View Letter (PDF)
Jan 27, 2010	SUPPL -1	View Letter (PDF)
Aug 21, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 12.5MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 15, 2008

No patent or exclusivity listings for this strength.

#002 — 25MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 15, 2008