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Drug ReportsMethotrexate
Methotrexate sodium, Nordimet(methotrexate)
Jylamvo, Methotrexate, Nordimet, Otrexup, Rasuvo, Trexall, Xatmep (methotrexate) is a small molecule pharmaceutical. Methotrexate was first approved as Methotrexate sodium on 1982-01-01. It is used to treat breast neoplasms, choriocarcinoma, crohn disease, esophageal neoplasms, and hydatidiform mole amongst others in the USA. It has been approved in Europe to treat arthritis, precursor cell lymphoblastic leukemia-lymphoma, psoriasis, psoriatic arthritis, and rheumatoid arthritis. The pharmaceutical is active against dihydrofolate reductase. In addition, it is known to target reduced folate transporter and proton-coupled folate transporter.
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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
musculoskeletal diseasesD009140
digestive system diseasesD004066
respiratory tract diseasesD012140
urogenital diseasesD000091642
hemic and lymphatic diseasesD006425
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
immune system diseasesD007154
Trade Name
FDA
EMA
Jylamvo, Methotrexate, Otrexup, Rasuvo, Trexall, Xatmep (discontinued: Folex, Methotrexate, Mexate, Mexate-aq, Mexate-aq preserved, Otrexup, Rasuvo, Reditrex)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Methotrexate sodium
Tradename
Company
Number
Date
Products
XATMEPAzurityN-208400 RX2017-04-25
1 products, RLD, RS
METHOTREXATE SODIUMHospiraN-011719 RX2004-12-15
1 products, RLD, RS
METHOTREXATE SODIUM PRESERVATIVE FREEHospiraN-011719 RX2005-04-13
1 products, RLD, RS
Show 5 discontinued
Methotrexate
Tradename
Company
Number
Date
Products
RASUVOMedexus PharmaceuticalsN-205776 RX2014-07-10
9 products, RLD, RS
OTREXUPOtter PharmaceuticalsN-204824 RX2013-10-11
7 products, RLD, RS
JYLAMVOShorla PharmaN-212479 RX2022-11-29
1 products, RLD, RS
Show 5 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
jylamvoNew Drug Application2024-10-30
methotrexateANDA2024-12-05
methotrexate sodiumANDA2024-03-01
otrexupNew Drug Application2024-12-24
rasuvoNew Drug Application2024-12-06
trexallANDA2021-04-30
xatmepNew Drug Application2022-06-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
leukemia—D007938C95
juvenile arthritisEFO_1002007D001171M08
breast neoplasmsEFO_0003869D001943C50
psoriasisEFO_0000676D011565L40
stomach neoplasmsEFO_0003897D013274C16
esophageal neoplasms—D004938C15
rheumatoid arthritisEFO_0000685D001172M06.9
lung neoplasmsHP_0100526D008175C34.90
crohn diseaseEFO_0000384D003424K50
hydatidiform mole—D006828O01
Show 4 more
Agency Specific
FDA
EMA
Expiration
Code
METHOTREXATE SODIUM, XATMEP, AZURITY
2024-04-25ODE-137, ODE-138
Patent Expiration
Patent
Expires
Flag
FDA Information
Methotrexate Sodium, Xatmep, Azurity
92594272033-01-02DP
98552152033-01-02DP
102319272033-01-02U-1349, U-1699
106104852033-01-02DP
111167242033-01-02U-1349, U-1699
Methotrexate, Otrexup, Otter Pharms
88148342031-05-27DP
84806312030-03-19DPU-1442
85798652030-03-19DPU-1442
89450632030-03-19DPU-1442
94213332030-03-19DPU-1442
114977532030-03-19DP
98679492029-03-10DP
107098442029-03-10DP
80213352026-10-04DP
85625642026-01-24DP
95331022026-01-24DP
96299592026-01-24DP
114464412026-01-24DP
Methotrexate, Rasuvo, Medexus
86642312029-06-01U-1442
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01B: Antimetabolites
— L01BA: Folic acid analogs, antimetabolites
— L01BA01: Methotrexate
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AX: Other immunosuppressants in atc
— L04AX03: Methotrexate
HCPCS
Code
Description
J8610
Methotrexate; oral, 2.5 mg
J9250
Methotrexate sodium, 5 mg
J9260
Methotrexate sodium, 50 mg
Clinical
Clinical Trials
2197 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ArthritisD001168HP_0001369M05-M147323223012989723
Rheumatoid arthritisD001172EFO_0000685M06.96922621112280679
LeukemiaD007938—C95982601102137465
LymphomaD008223—C85.970216581129342
Precursor cell lymphoblastic leukemia-lymphomaD054198——65170872129335
Lymphoid leukemiaD007945—C9158149661922283
Non-hodgkin lymphomaD008228—C85.926682927116
Graft vs host diseaseD006086—D89.811652205585
SyndromeD013577——224892878
PsoriasisD011565EFO_0000676L405513232972
Show 117 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190—D46286919—7108
Myeloid leukemia acuteD015470—C92.0254623—388
Myeloid leukemiaD007951—C92225018—386
PreleukemiaD011289——235314—684
Breast neoplasmsD001943EFO_0003869C5062832—871
NeoplasmsD009369—C8016388—1165
Myeloproliferative disordersD009196—D47.19404—450
Multiple myelomaD009101—C90.012301—441
Hematologic neoplasmsD019337——16284—240
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—4298—140
Show 108 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Plasma cell neoplasmsD054219——621——428
PlasmacytomaD010954—C90.3418——423
Myeloid leukemia chronic-phaseD015466——216———16
Blast crisisD001752——214———14
Myeloid leukemia accelerated phaseD015465——113———13
Healthy volunteers/patients———111——113
Primary myelofibrosisD055728—D47.427——211
Lymphoproliferative disordersD008232Orphanet_2442D47.917——210
Neurotoxicity syndromesD020258—G9223——48
Invasive hydatidiform moleD002820—D39.224——17
Show 121 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Retinal diseasesD012164HP_0000479H35.91———12
MelanomaD008545——2————2
PharmacokineticsD010599——2————2
Drug interactionsD004347——2————2
Male breast neoplasmsD018567——1————1
HeadacheD006261HP_0002315R511————1
Neck painD019547HP_0030833M54.21————1
Sleep wake disordersD012893—G471————1
Plasma cell leukemiaD007952—C90.11————1
Chronic progressive multiple sclerosisD020528EFO_0003840—1————1
Show 20 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Knee osteoarthritisD020370EFO_0004616M17————33
Papillomavirus infectionsD030361——————22
Skin diseasesD012871—L00-L99————22
Diabetes mellitusD003920HP_0000819E08-E13————22
Granulomatous mastitisD058890—N61.2————22
MastitisD008413EFO_1001034N61————22
Chediak-higashi syndromeD002609Orphanet_167D72.0————22
Localized sclerodermaD012594EFO_1001361L94.0————11
Respiratory tract infectionsD012141—J06.9————11
PapillomaviridaeD027383——————11
Show 79 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMethotrexate
INNmethotrexate
Description
Methotrexate is a member of pteridines, a monocarboxylic acid amide and a dicarboxylic acid. It has a role as an antineoplastic agent, an antirheumatic drug, an EC 1.5.1.3 (dihydrofolate reductase) inhibitor, a DNA synthesis inhibitor, an abortifacient, a dermatologic drug, an antimetabolite and an immunosuppressive agent. It is functionally related to a L-glutamic acid. It is a conjugate acid of a methotrexate(1-).
Classification
Small molecule
Drug classantimetabolites (folic acid derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1
Identifiers
PDB—
CAS-ID59-05-2
RxCUI—
ChEMBL IDCHEMBL34259
ChEBI ID44185
PubChem CID126941
DrugBankDB00563
UNII IDYL5FZ2Y5U1 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Methotrexate – Pfizer
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Otrexup – Assertio Therapeutics
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Reditrex – Cumberland Pharmaceuticals
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Tabular view
Estimated US medical usage
Methotrexate
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 28,224 documents
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Safety
Black-box Warning
Black-box warning for: Jylamvo, Methotrexate sodium, Otrexup, Rasuvo, Trexall, Xatmep
Adverse Events
Top Adverse Reactions
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273,344 adverse events reported
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