VALGANCICLOVIR HYDROCHLORIDE | N021304 | CHEPLAPHARM ARZNEIMITTEL GMBH
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 2 | Active | Cecilia Soderberg-Naucler | 220 | 2019-09-04 → 2027-09-16 | |
| Phase 2 | Active | National Cancer Institute (NCI) | 75 | 2004-10-28 → 2026-10-01 | |
| Phase 2 | Active | Albert Park | 52 | 2018-08-31 → 2024-07 | |
| Phase 1/2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 130 | 2004-03 → 2010-11 | |
| Phase 3 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 350 | 2000-08 → 2006-02 | |
| Phase 1/2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 24 | 2002-07 → 2007-07 | |
| Phase 2 | Completed | National Institute of Cancerología | 40 | 2015-10-01 → 2019-08-26 | |
| Phase 2/3 | Completed | Hospital Universitario 12 de Octubre | 563 | 2020-03-01 → 2025-01-31 | |
| N/A | Completed | Hoffmann-La Roche | 200 | — | |
| Phase 4 | Completed | National Institutes of Health Clinical Center (CC) | 12 | 2002-04-24 → 2009-10-30 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
Lowest Price
$3970.38
Highest Price
$4957.64
FSS NDCs
1
Big4 NDCs
1
| Description | Price | Type | Vendor | Contract End |
|---|---|---|---|---|
| 61269-0480-60VALGANCICLOVIR HCL 450MG TAB | $4957.64 | FSS | H2-Pharma, LLC | 10/01/2026 |
| 61269-0480-60VALGANCICLOVIR HCL 450MG TAB | $3970.38 | Big4 | H2-Pharma, LLC | 10/01/2026 |
Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.
Total Spending
$85K
Total Claims
12
Beneficiaries
—
Avg Cost/Unit
$73.41
Spending Trend
Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.
15 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 |
|---|---|---|
| Dec 27, 2021 | SUPPL -17 | View Letter (PDF) |
| Nov 27, 2020 | SUPPL -16 | View Letter (PDF) |
| Oct 23, 2020 | SUPPL -15 | View Letter (PDF) |
| Aug 3, 2018 | SUPPL -14 | View Letter (PDF) |
| Jun 26, 2017 | SUPPL -12 | View Letter (PDF) |
| Apr 24, 2015 | SUPPL -11 | View Letter (PDF) |
| Apr 1, 2013 | SUPPL -10 | View Letter (PDF) |
| Aug 10, 2010 | SUPPL -8 | View Letter (PDF) |
| Sep 1, 2009 | SUPPL -7 | View Letter (PDF) |
| Feb 2, 2006 | SUPPL -4 | View Letter (PDF) |
| Sep 25, 2003 | SUPPL -1 | View Letter (PDF) |
| Mar 29, 2001 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.