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Drug ReportsMethotrexate
Methotrexate sodium, Nordimet(methotrexate)
Jylamvo, Methotrexate, Nordimet, Otrexup, Rasuvo, 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
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, Otrexup, Rasuvo, Reditrex, Xatmep (generic drugs available since 1986-09-16, discontinued: Abitrexate, Folex, Mexate, Mexate-aq, Mexate-aq preserved)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Calcium chloride
+
Dextrose
+
Glutathione disulfide
+
Magnesium chloride
+
Potassium chloride
+
Sodium bicarbonate
+
Sodium chloride
+
Sodium phosphate
Tradename
Company
Number
Date
Products
METHOTREXATE SODIUMAkornN-020079 DISCN1999-02-26
1 products
Hide discontinued
Methotrexate
Tradename
Company
Number
Date
Products
RASUVOMedexus PharmaceuticalsN-205776 RX2014-07-10
9 products, RLD, RS
REDITREXNordic PharmaN-210737 RX2019-11-27
3 products, RLD, RS
OTREXUPOtter PharmaceuticalsN-204824 RX2013-10-11
7 products, RLD, RS
JYLAMVOTherakindN-212479 RX2022-11-29
1 products, RLD, RS
Show 5 discontinued
Methotrexate sodium
Tradename
Company
Number
Date
Products
XATMEPAzurityN-208400 RX2017-04-25
1 products, RLD, RS
METHOTREXATE SODIUM PRESERVATIVE FREEHospiraN-011719 RX2005-04-13
1 products, RLD, RS
METHOTREXATE SODIUMHospiraN-011719 RX2004-12-15
1 products, RLD, RS
Show 5 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
jylamvoNew Drug Application2023-12-01
methotrexateANDA2024-01-09
methotrexate sodiumANDA2020-08-27
otrexupNew Drug Application2023-12-14
rasuvoNew Drug Application2023-09-01
reditrexNew Drug Application2019-12-11
trexallANDA2021-04-30
xatmepNew Drug Application2022-06-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
choriocarcinoma—D002822C58
crohn diseaseEFO_0000384D003424K50
esophageal neoplasms—D004938C15
hydatidiform mole—D006828O01
juvenile arthritisEFO_0002609D001171M08
leukemia—D007938C95
lung neoplasms—D008175C34.90
mycosis fungoides—D009182C84.0
osteosarcoma—D012516—
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
2142 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rheumatoid arthritisD001172EFO_0000685M06.96922120711872658
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.056114532019235
PsoriasisD011565EFO_0000676L404413222464
Graft vs host diseaseD006086—D89.811339112558
Non-hodgkin lymphomaD008228—C85.982762343
Large b-cell lymphoma diffuseD016403—C83.382072134
Psoriatic arthritisD015535EFO_0003778L40.5331051031
Juvenile arthritisD001171EFO_1002007M082193722
Burkitt lymphomaD002051—C83.7415—2120
Crohn diseaseD003424EFO_0000384K50——210719
Show 65 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C952210944—13166
LymphomaD008223—C85.9177823—12120
Myelodysplastic syndromesD009190—D46266114—794
Myeloid leukemia acuteD015470—C92.0203520—370
Breast neoplasmsD001943EFO_0003869C5062631—565
OsteosarcomaD012516——5175—731
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—4187—128
Hodgkin diseaseD006689—C814165——23
Urinary bladder neoplasmsD001749—C67—167——22
Central nervous system neoplasmsD016543——5112—520
Show 73 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Plasma cell neoplasmsD054219——417——422
NeoplasmsD009369—C80811——622
Myeloproliferative disordersD009196—D47.1617——321
Hematologic neoplasmsD019337——711——116
Myeloid leukemia chronic-phaseD015466——113———13
B-cell lymphomaD016393——37———9
Primary myelofibrosisD055728—D47.425——18
Myeloid leukemia accelerated phaseD015465——18———8
Precursor t-cell lymphoblastic leukemia-lymphomaD054218——45———7
T-cell lymphoma peripheralD016411——25———7
Show 85 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———11———112
Myeloid leukemiaD007951—C923————3
MelanomaD008545——2————2
PharmacokineticsD010599——2————2
Drug interactionsD004347——2————2
Male breast neoplasmsD018567——1————1
HeadacheD006261HP_0002315R511————1
Plasma cell leukemiaD007952—C90.11————1
HypersensitivityD006967HP_0012393T78.401————1
SyndromeD013577——1————1
Show 10 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Liver cirrhosisD008103EFO_0001422K74.0————44
Neurotoxicity syndromesD020258—G92————22
Knee osteoarthritisD020370EFO_0004616M17————22
Chediak-higashi syndromeD002609Orphanet_167D72.0————22
PapillomaviridaeD027383——————11
Alzheimer diseaseD000544EFO_0000249F03————11
DementiaD003704EFO_0003862F03————11
LactationD007774——————11
Squamous intraepithelial lesionsD000081483——————11
ScleritisD015423HP_0100534H15.0————11
Show 44 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)
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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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Reditrex – Cumberland Pharmaceuticals
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Otrexup – Assertio Therapeutics
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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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 118,904 documents
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Safety
Black-box Warning
Black-box warning for: Jylamvo, Methotrexate, Methotrexate sodium, Otrexup, Rasuvo, Reditrex, Trexall, Xatmep
Adverse Events
Top Adverse Reactions
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202,062 adverse events reported
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