TETRABENAZINE | N021894 | BAUSCH HEALTH US LLC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 3 | Completed | Prestwick Pharmaceuticals | — | — | |
| Phase 1 | Completed | Dr. Reddy's Laboratories Limited | 48 | 2015-10 → 2015-11 | |
| Phase 3 | Completed | Centre Hospitalier Universitaire, Amiens | 54 | 2012-05-14 → 2017-08 | |
| N/A | Completed | Centre for Addiction and Mental Health | 41 | 2002-02 → 2006-01 | |
| Phase 4 | Completed | New York Medical College | 2 | 2013-03 → 2018-01-01 | |
| Phase 1 | Completed | Dr. Reddy's Laboratories Limited | 48 | 2015-12 → 2015-12 | |
| Phase 3 | Completed | Assistance Publique - Hôpitaux de Paris | 180 | 2009-04 → 2017-04-28 | |
| — | NO_LONGER_AVAILABLE | Joseph Jankovic | — | — | |
| Phase 4 | UNKNOWN | William Ondo, MD | 20 | 2018-08-01 → 2023-07-01 | |
| Phase 2 | Withdrawn | Bausch Health Americas, Inc. | — | 2011-03 → 2011-12 |
Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.
Lowest Price
$124.99
Highest Price
$35363.32
FSS NDCs
4
Big4 NDCs
4
| Description | Price | Type | Vendor | Contract End |
|---|---|---|---|---|
| 67386-0421-01XENAZINE 12.5MG TAB | $15920.60 | Big4 | Lundbeck LLC | 09/30/2026 |
| 67386-0421-01XENAZINE 12.5MG TAB | $17681.77 | FSS | Lundbeck LLC | 09/30/2026 |
| 67386-0422-01XENAZINE 25MG TAB | $31841.22 | Big4 | Lundbeck LLC | 09/30/2026 |
| 67386-0422-01XENAZINE 25MG TAB | $35363.32 | FSS | Lundbeck LLC | 09/30/2026 |
| 68682-0421-12TETRABENAZINE 12.5MG TAB | $202.89 | Big4 | Bausch Health US, LLC | 04/30/2026 |
| 68682-0421-12TETRABENAZINE 12.5MG TAB | $202.89 | FSS | Bausch Health US, LLC | 04/30/2026 |
| 68682-0422-25TETRABENAZINE 25MG TAB | $124.99 | Big4 | Bausch Health US, LLC | 04/30/2026 |
| 68682-0422-25TETRABENAZINE 25MG TAB | $351.76 | FSS | Bausch Health US, LLC | 04/30/2026 |
Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.
Total Spending
$5.6M
Total Claims
151
Beneficiaries
23
Avg Cost/Unit
$291.08
Spending Trend
Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.
11 active API suppliers hold Drug Master Files for this ingredient.
Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.
| 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.
No patent or exclusivity listings for this strength.