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Last Updated: December 14, 2019

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Methotrexate - Generic Drug Details

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What are the generic sources for methotrexate and what is the scope of patent protection?

Methotrexate is the generic ingredient in fifteen branded drugs marketed by Antares Pharma Inc, Medexus, Abic, Pharmacia And Upjohn, Hospira, Fresenius Kabi Usa, Abraxis Pharm, Norbrook, Pharmachemie Usa, West-ward Pharms Int, Accord Hlthcare, Mylan Labs Ltd, Pharmachemie Bv, Sagent Pharms Inc, Sandoz Inc, Bristol, Bristol Myers, Bristol Myers Squibb, Silvergate Pharms, Amneal Pharms, Barr, Dava Pharms Inc, Duramed Pharms Barr, Mylan, Sun Pharm, and Zydus Pharms, and is included in forty-nine NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Methotrexate has sixty-seven patent family members in twenty-three countries.

There are twenty drug master file entries for methotrexate. Two suppliers are listed for this compound.

Drug Prices for methotrexate

See drug prices for methotrexate

Drug Sales Revenue Trends for methotrexate

See drug sales revenues for methotrexate

Recent Clinical Trials for methotrexate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Barbara Ann Karmanos Cancer InstitutePhase 3
University of Michigan Rogel Cancer CenterPhase 3
Indiana University School of MedicinePhase 3

See all methotrexate clinical trials

Recent Litigation for methotrexate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Antares Pharma Inc. v. Medac Pharma Inc.2014-07-21
Antares Pharma Inc. v. Medac Pharma Inc.2014-02-28

See all methotrexate litigation

PTAB Litigation
PetitionerDate
Koios Pharmaceuticals LLC2016-07-20
Frontier Therapeutics, LLC2016-02-22
Antares Pharma, Inc.2014-07-01

See all methotrexate litigation

Pharmacology for methotrexate
Synonyms for methotrexate
(+)-4-Amino-10-methylfolic acid
(2S)-2-[(4-{[(2,4-diaminopteridin-6-yl)methyl](methyl)amino}phenyl)formamido]pentanedioic acid
(2S)-2-[[[4-[(2,4-diamino-6-pteridinyl)methyl-methylamino]phenyl]-oxomethyl]amino]pentanedioic acid;hydrate
(2S)-2-[[4-[(2,4-diaminopteridin-6-yl)methyl-methyl-amino]benzoyl]amino]glutaric acid;hydrate
(2S)-2-[[4-[(2,4-diaminopteridin-6-yl)methyl-methyl-amino]benzoyl]amino]pentanedioic acid
(2S)-2-[[4-[(2,4-diaminopteridin-6-yl)methyl-methylamino]benzoyl]amino]pentanedioic acid
(2S)-2-[[4-[(2,4-diaminopteridin-6-yl)methyl-methylamino]benzoyl]amino]pentanedioic acid;hydrate
(2S)-2-[[4-[[2,4-bis(azanyl)pteridin-6-yl]methyl-methyl-amino]phenyl]carbonylamino]pentanedioic acid;hydrate
(4-(((2,4-diaminopteridin-6-yl)methyl)(methyl)amino)benzoyl)-L-glutamic acid
(methyl)amino)benzamido)pentanedioic acid
(S)-2-(4-(((2,4-diaminopteridin-6-yl)methyl)
(S)-2-(4-(((2,4-Diaminopteridin-6-yl)methyl)(methyl)amino)benzamido)pentanedioic acid
[3H]-methotrexate
[3H]methotrexate
1082707-84-3
133073-73-1
15475-56-6 (hydrochloride salt)
1771-EP0930075A1
1771-EP2269989A1
1771-EP2269994A1
1771-EP2270001A1
1771-EP2270008A1
1771-EP2270018A1
1771-EP2270505A1
1771-EP2272825A2
1771-EP2272827A1
1771-EP2272832A1
1771-EP2275413A1
1771-EP2275420A1
1771-EP2277565A2
1771-EP2277566A2
1771-EP2277567A1
1771-EP2277568A2
1771-EP2277569A2
1771-EP2277570A2
1771-EP2277865A1
1771-EP2277876A1
1771-EP2280012A2
1771-EP2281563A1
1771-EP2281815A1
1771-EP2287156A1
1771-EP2289892A1
1771-EP2289894A2
1771-EP2292233A2
1771-EP2292280A1
1771-EP2292595A1
1771-EP2292614A1
1771-EP2292615A1
1771-EP2292617A1
1771-EP2295055A2
1771-EP2295416A2
1771-EP2295426A1
1771-EP2295427A1
1771-EP2298743A1
1771-EP2298748A2
1771-EP2298764A1
1771-EP2298765A1
1771-EP2298768A1
1771-EP2298772A1
1771-EP2298778A1
1771-EP2298780A1
1771-EP2301928A1
1771-EP2301933A1
1771-EP2305243A1
1771-EP2305640A2
1771-EP2305642A2
1771-EP2305660A1
1771-EP2305668A1
1771-EP2305671A1
1771-EP2305679A1
1771-EP2305689A1
1771-EP2308833A2
1771-EP2308839A1
1771-EP2308855A1
1771-EP2308861A1
1771-EP2311453A1
1771-EP2311807A1
1771-EP2311808A1
1771-EP2311825A1
1771-EP2311827A1
1771-EP2311829A1
1771-EP2311840A1
1771-EP2311842A2
1771-EP2311850A1
1771-EP2314590A1
1771-EP2316459A1
1771-EP2316832A1
1771-EP2316833A1
1771-EP2316834A1
1771-EP2371811A2
1771-EP2374454A1
1dhi
1dhj
2,2'-(9,10-anthracenediylidene)-bis-propanedinitrile
2drc
4-Amino-10-methylfolic acid
4-Amino-10-methylfolic acid hydrate
4-amino-N(10)-methylpteroylglutamic acid
4-Amino-N(sup 10)-methylpteroylglutamic acid
4-Aminomethylpteroylglutamic acid
4kn0
4ocx
59-05-2
5947-EP0930075A1
5947-EP2269994A1
5947-EP2289892A1
70359-39-6
73M731
7413-34-5 (di-hydrochloride salt)
A-2190
A-Methopterin
A-Methpterin
AB02593
Abitrexate
Abitrexate (Methotrexate)
AC1L2R79
ACN-050905
ACT03341
AI3-25299
AJ-26587
AK-77824
AKOS016340329
Amethopterin
Amethopterin L-
Amethopterine
An-PDN
Antifolan
Antifolan hydrate
ANW-72813
AOB5585
APC-2002
Arbitrexate
BC202627
BCP13701
BDBM18050
BDBM66082
BIDD:PXR0175
Bio1_000486
Bio1_000975
Bio1_001464
BR-77824
BRD-K59456551-001-09-3
BRD-K59456551-001-11-9
Brimexate
C01937
C20H22N8O5
CAS-59-05-2
CCG-35800
CCRIS 1109
CHEBI:44185
CHEMBL34259
cid_126941
cid_165528
CL 14377
CL-14377
CL14377
CS-1732
CTK1G9789
D00142
DB00563
DivK1c_000114
DL-4-Amino-N10-methylpteroylglutamic acid hydrate
DL-Amethopterin hydrate
DSSTox_CID_822
DSSTox_GSID_20822
DSSTox_RID_75810
DTXSID4020822
EINECS 200-413-8
EMT 25,299
Emtexate
Emthexat
Emthexate
EU-0100020
Fauldexato
FBOZXECLQNJBKD-UHFFFAOYSA-N
FBOZXECLQNJBKD-ZDUSSCGKSA-N
Folex
Folex-Pfs
folic acid antagonist
FT-0082628
FT-0601523
g301
Glutamic acid, N-(p-(((2,4-diamino-6-pteridinyl)methyl)methylamino)benzoyl)-, L-
Glutamic acid,4-diamino-6-pteridinyl)methyl] methylamino]benzoyl]-, L-(+)-
GTPL4674
GTPL4815
Hdmtx
HMS1568K12
HMS2095K12
HMS2233O18
HMS3260C21
HMS3712K12
HMS500F16
HSDB 3123
HY-14519
I06-2098
I14-18123
IDI1_000114
Intradose-MTX
Intrathecal methotrexate
J10045
KBio1_000114
KBio2_002338
KBio2_004906
KBio2_007474
KBio3_001493
KBioGR_001172
KBioSS_002341
KS-00000L8X
KS-5093
KSC269O8T
Kyselina 4-amino-N(sup 10)-methylpteroylglutamova
Kyselina 4-amino-N(sup 10)-methylpteroylglutamova [Czech]
Kyselina N-(p-((2,4-diamino-6-pteridinylmethyl)methylamino)benzoyl)-L-glutamova
Kyselina N-(p-((2,4-diamino-6-pteridinylmethyl)methylamino)benzoyl)-L-glutamova [Czech]
L-(+)-N-(p-(((2,4-Diamino-6-pteridinyl)methyl)methylamino)benzoyl)glutamic acid
L-Amethopterin
L-Glutamic acid,4-diamino-6-pteridinyl)methyl]- methylamino]benzoyl]-
L-Glutamic acid,N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-, hydrate (9CI)
L-Glutamic acid,N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-,hydrate(9ci)
L-Glutamicacid, N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-
L(+)-Amethopterin hydrate
Lantarel
Lopac0_000020
LP00020
LS-249
Lumexon
Maxtrex
MCULE-6523054194
Medsatrexate
Metatrexan
Metex
Methoblastin
Methotextrate
Methotrate
Methotrexat
Methotrexat-Ebewe
Methotrexate - Abitrexate
Methotrexate (JP17/USP/INN)
Methotrexate [USAN:INN:BAN:JAN]
Methotrexate [USAN:USP:INN:BAN:JAN]
Methotrexate 1.0 mg/ml in Dimethyl Sulfoxide
Methotrexate for peak identification, European Pharmacopoeia (EP) Reference Standard
Methotrexate for system suitability, European Pharmacopoeia (EP) Reference Standard
METHOTREXATE SODIUM
Methotrexate, European Pharmacopoeia (EP) Reference Standard
Methotrexate, L-
Methotrexate, Pharmaceutical Secondary Standard; Certified Reference Material
Methotrexate, PharmaGrade, Manufactured under appropriate controls for use as a raw material in pharma or biopharmaceutical production, meets EP, USP testing specifications
Methotrexate, United States Pharmacopeia (USP) Reference Standard
Methotrexatum
Methotrexatum [INN-Latin]
Methoxtrexate
Methylaminopterin
Methylaminopterin hydrate
Methylaminopterin; MTX
Methylaminopterinum
Metolate
Metotressato
Metotressato [DCIT]
Metotrexato
Metotrexato [INN-Spanish]
Metrotex
Mexate
Mexate-Aq
MFCD00150847
MLS000049968
MLS001401431
MLS002154208
MolPort-003-665-521
MPI-2505
MPI-5004
MTX
MTX hydrate
N-(4-(((2,4-Diamino-6-pteridinyl)methyl)methylamino)benzoyl)-L-glutamicacid
N-(4-{[(2,4-diaminopteridin-6-yl)methyl](methyl)amino}benzoyl)-L-glutamic acid
N-(p-(((2,4-Diamino-6-pteridinyl)methyl)methylamino)benzoyl)-L-(+)-glutamic acid
N-(p-(((2,4-Diamino-6-pteridyl)methyl)methylamino)benzoyl)glutamic acid
N-[(4-{[(2,4-diaminopteridin-6-yl)methyl](methyl)amino}phenyl)carbonyl]-L-glutamic acid
N-[4-[[(2,4-Diamino-6-pteridinyl)methyl] methylamino]benzoyl]-L-glutamic acid
N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-L-glutamic acid
N-{4-[[(2,4-diaminopteridin-6-yl)methyl](methyl)amino]benzoyl}-L-glutamic acid
N-Bismethylpteroylglutamic acid
NCGC00025060-01
NCGC00025060-02
NCGC00025060-03
NCGC00025060-04
NCGC00025060-05
NCGC00025060-06
NCGC00025060-07
NCGC00025060-08
NCGC00025060-09
NCGC00025060-10
NCGC00025060-11
NCGC00025060-12
NCGC00025060-13
NCGC00025060-15
NCGC00025060-16
NCGC00254216-01
NCGC00260705-01
NCI-C04671
NCIMech_000767
NINDS_000114
Nordimet
Novatrex
NSC 740
NSC-740
NSC740
Otrexup
Otrexup (TN)
Prestwick_322
Prestwick0_000135
Prestwick1_000135
Prestwick2_000135
Q-201366
R 9985
Rasuvo
Rheumatrex
RTR-020497
s1210
SC-19293
SCHEMBL12421860
SCHEMBL3711
SMP2_000020
SMR000112001
SMR000449324
SPBio_001094
SPBio_002149
Spectrum_001836
Spectrum2_001077
Spectrum3_000497
Spectrum4_000616
Spectrum5_000958
SR-01000075682
SR-01000075682-1
SR-01000075682-2
SR-01000075682-6
SR-01000597411
SR-01000597411-1
STL535338
SW198601-3
TCMDC-125858
Texate
Tocris-1230
Tox21_110944
Tox21_110944_1
Tox21_300269
Tox21_500020
Tremetex
Trexall
Trexeron
Trixilem
UNII-99ITO15X8S component FBOZXECLQNJBKD-ZDUSSCGKSA-N
UNII-YL5FZ2Y5U1
W-105347
W-60383
WLN: T66 BN DN GN JNJ CZ EZ H1N1&R DVMYVQ2VQ
WR-19039
X 133
Xatmep
Xatmep (TN)
YL5FZ2Y5U1
Z1541638527
ZINC1529323

US Patents and Regulatory Information for methotrexate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr TREXALL methotrexate sodium TABLET;ORAL 040385-004 Mar 21, 2001 RX No Yes   Start Trial   Start Trial   Start Trial
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-001 Oct 11, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Fresenius Kabi Usa METHOTREXATE SODIUM methotrexate sodium INJECTABLE;INJECTION 040263-001 Feb 26, 1999 AP RX No Yes   Start Trial   Start Trial   Start Trial
West-ward Pharms Int METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 089343-001 Sep 16, 1986 AP RX No Yes   Start Trial   Start Trial   Start Trial
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-004 Oct 11, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-004 Oct 11, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for methotrexate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-006 Mar 24, 2016   Start Trial   Start Trial
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-002 Oct 11, 2013   Start Trial   Start Trial
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-007 Mar 24, 2016   Start Trial   Start Trial
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-002 Oct 11, 2013   Start Trial   Start Trial
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-004 Oct 11, 2013   Start Trial   Start Trial
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-005 Nov 7, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Boehringer Ingelheim
Express Scripts
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Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.