NELFINAVIR MESYLATE | N021503 | AGOURON PHARMACEUTICALS LLC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 1 | Recruiting | M.D. Anderson Cancer Center | 25 | 2020-08-07 → 2026-12-31 | |
| Phase 1 | Completed | Mayo Clinic | 9 | 2019-04-17 → 2023-11-24 | |
| Phase 4 | Completed | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | — | 2000-11 → 2001-11 | |
| N/A | Completed | Bristol-Myers Squibb | — | 1997-05 → 2000-03 | |
| N/A | Completed | Triangle Pharmaceuticals | — | — | |
| N/A | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 90 | 2001-03 → 2004-05 | |
| N/A | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 398 | 2003-02 → 2008-10 | |
| Phase 1 | Completed | Abramson Cancer Center at Penn Medicine | 31 | 2009-04 → 2017-12 | |
| Phase 2 | Completed | Swiss Cancer Institute | 34 | 2014-12-02 → 2018-04-17 | |
| Phase 3 | Completed | Hoffmann-La Roche | 120 | — |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
Lowest Price
$908.73
Highest Price
$1195.70
FSS NDCs
1
Big4 NDCs
1
| Description | Price | Type | Vendor | Contract End |
|---|---|---|---|---|
| 63010-0027-70VIRACEPT 625MG TAB | $1195.70 | FSS | Pfizer Inc. | 06/30/2029 |
| 63010-0027-70VIRACEPT 625MG TAB | $908.73 | Big4 | Pfizer Inc. | 06/30/2029 |
Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.
0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.
Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.
| Date | Submission | Document |
|---|---|---|
| Mar 25, 2021 | SUPPL -25 | View Letter (PDF) |
| Sep 22, 2016 | SUPPL -24 | View Letter (PDF) |
| Mar 31, 2015 | SUPPL -23 | View Letter (PDF) |
| May 31, 2013 | SUPPL -21 | View Letter (PDF) |
| Apr 11, 2012 | SUPPL -18 | View Letter (PDF) |
| Feb 27, 2012 | SUPPL -20 | View Letter (PDF) |
| Feb 28, 2011 | SUPPL -17 | View Letter (PDF) |
| Apr 28, 2010 | SUPPL -16 | View Letter (PDF) |
| Apr 28, 2010 | SUPPL -15 | View Letter (PDF) |
| Nov 26, 2008 | SUPPL -14 | View Letter (PDF) |
| Feb 14, 2008 | SUPPL -11 | View Letter (PDF) |
| Jan 8, 2007 | SUPPL -7 | View Letter (PDF) |
| Oct 20, 2005 | SUPPL -6 | View Letter (PDF) |
| Jun 7, 2004 | SUPPL -3 | View Letter (PDF) |
| Mar 24, 2004 | SUPPL -1 | View Letter (PDF) |
| Aug 29, 2003 | SUPPL -2 | View Letter (PDF) |
| May 29, 2003 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.