Sold as Otrexup, Otrexup Pfs, Rasuvo, Reditrex, Jylamvo and 1 more. Every FDA application for this active ingredient.
As of Nov 13, 2026, FDA lists 5 applications for Methotrexate (sold as Otrexup, Otrexup Pfs, Rasuvo and others), first approved Oct 11, 2013, with 3 new uses approved and 1 published complete response letter.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Methotrexate | Part D | $55.1M | -4% | 569,550 |
| Trexall | Part D | $2.4M | +3% | 1,931 |
| Xatmep | Part D | $279K | +13% | 86 |
| Methotrexate (J9260) | Part B | $112K | +8% | 4,602 |
| Jylamvo | Part D | $26K | New | 12 |
| Methotrexate (J8610) | Part B | $2K | -37% | 96 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Oct 11, 2013 | Otrexup, Otrexup PfsNDA 204824 · Efficacy (new indication or use) | Cosette | 9 | Discontinued |
| Jul 10, 2014 | RasuvoNDA 205776 · New formulation or manufacturer | Medexus | 3 | Marketed |
| Nov 27, 2019 | ReditrexNDA 210737 · New formulation or manufacturer | Nordic Grp | 1 | Discontinued |
| Aug 24, 2020 | MethotrexateNDA 214121 · New formulation or manufacturer | Accord Hlthcare | 5 | Discontinued |
| Nov 29, 2022 | JylamvoNDA 212479 · New formulation or manufacturer | Shorla | 3 | Marketed |
| Letter | Product | Now |
|---|---|---|
| Dec 22, 2021 | Jylamvo (methotrexate)Product Quality | Approved |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number. Drugs@FDA
