METHOTREXATE | N214121 | ACCORD HEALTHCARE INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 3 | Active | National Cancer Institute (NCI) | 488 | 2014-05-19 → 2027-02-25 | |
| Phase 2 | Active | National Cancer Institute (NCI) | 53 | 2015-06-30 → 2027-06-06 | |
| Phase 2 | Active | Janssen Research & Development, LLC | 68 | 2023-05-18 → 2027-03-31 | |
| Phase 3 | Active | National Cancer Institute (NCI) | 669 | 2014-12-17 → 2026-09-16 | |
| Phase 3 | Active | Children's Oncology Group | 66 | 2023-03-15 → 2027-07-07 | |
| Phase 2 | Active | Children's Oncology Group | 80 | 2017-06-19 → 2026-12-31 | |
| Phase 3 | Active | National Cancer Institute (NCI) | 847 | 2014-10-04 → 2026-09-16 | |
| Phase 3 | Active | Boston Children's Hospital | 53 | 2023-01-25 → 2029-12 | |
| Phase 3 | Active | National Cancer Institute (NCI) | 6,720 | 2019-07-03 → 2027-09-30 | |
| Phase 2 | Active | Memorial Sloan Kettering Cancer Center | 17 | 2020-03-30 → 2027-03 |
Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.
Total Spending
$57.2M
Total Claims
2,414,242
Beneficiaries
551,528
Avg Cost/Unit
$0.63
Spending Trend
Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.
8 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 |
|---|---|---|
| Mar 16, 2026 | SUPPL -5 | View Letter (PDF) |
| Jun 2, 2025 | SUPPL -3 | View Letter (PDF) |
| Jun 2, 2025 | SUPPL -4 | View Letter (PDF) |
| Mar 11, 2022 | SUPPL -1 | View Letter (PDF) |
| Aug 25, 2020 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.