DrugPatentWatch Database Preview
Methotrexate sodium - Generic Drug Details
What are the generic drug sources for methotrexate sodium and what is the scope of freedom to operate?
Methotrexate sodium
is the generic ingredient in twelve branded drugs marketed by 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, Hikma, Mylan, Sun Pharm, and Zydus Pharms, and is included in forty-seven NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Methotrexate sodium has three patent family members in three countries.
There are twenty drug master file entries for methotrexate sodium. Twenty-one suppliers are listed for this compound.
Summary for methotrexate sodium
| International Patents: | 3 |
| US Patents: | 3 |
| Tradenames: | 12 |
| Applicants: | 25 |
| NDAs: | 47 |
| Drug Master File Entries: | 20 |
| Suppliers / Packagers: | 21 |
| Bulk Api Vendors: | 143 |
| Clinical Trials: | 21 |
| Patent Applications: | 7,183 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | methotrexate sodium at DailyMed |
Recent Clinical Trials for methotrexate sodium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute for Health Research, United Kingdom | Phase 4 |
| University of Oxford | Phase 4 |
| Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
Pharmacology for methotrexate sodium
| Drug Class | Folate Analog Metabolic Inhibitor |
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Synonyms for methotrexate sodium
| (+)-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 |
| 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 |
| 33828-EP2275420A1 |
| 33828-EP2295055A2 |
| 33828-EP2295416A2 |
| 33828-EP2298748A2 |
| 33828-EP2298764A1 |
| 33828-EP2298765A1 |
| 33828-EP2305642A2 |
| 33828-EP2308861A1 |
| 33828-EP2311453A1 |
| 3IG1E710ZN |
| 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-Amino-N(sup 10)-methylpteroylglutamic acid disodium salt |
| 4-Amino-N10-methylpteroyl glutamate sodium |
| 4-Aminomethylpteroylglutamic acid |
| 4kn0 |
| 4ocx |
| 59-05-2 |
| 59-05-2 (Parent) |
| 5947-EP0930075A1 |
| 5947-EP2269994A1 |
| 5947-EP2289892A1 |
| 70359-39-6 |
| 73M731 |
| 7413-34-5 |
| 7413-34-5 (di-hydrochloride salt) |
| 7532-09-4 |
| 87WE99J27Z |
| A-2190 |
| A-Methopterin |
| A-Methpterin |
| AB02593 |
| Abitextrate |
| Abitrexate |
| Abitrexate (Methotrexate) |
| AC-7462 |
| AC1L2R79 |
| ACN-050905 |
| ACT03341 |
| AI3-25299 |
| AJ-26587 |
| AK-77824 |
| AKOS016340329 |
| AKOS025311236 |
| Amethopterin |
| Amethopterin L- |
| Amethopterin sodium |
| Amethopterine |
| An-PDN |
| Antifolan |
| Antifolan hydrate |
| ANW-72813 |
| AOB5585 |
| APC-2002 |
| API0007714 |
| Arbitrexate |
| AS-16128 |
| BC202627 |
| BC681885 |
| BCP13700 |
| 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 |
| C20H20N8Na2O5 |
| C20H22N8O5 |
| CAS-59-05-2 |
| CCG-35800 |
| CCRIS 1109 |
| CHEBI:44185 |
| CHEBI:50679 |
| CHEMBL3244648 |
| CHEMBL34259 |
| cid_126941 |
| cid_165528 |
| CL 14377 |
| CL-14377 |
| CL14377 |
| CS-1732 |
| CTK1G9789 |
| CTK5E1428 |
| D00142 |
| D02115 |
| DB00563 |
| disodium (2S)-2-(4-{[(2,4-diaminopteridin-6-yl)methyl](methyl)amino}benzamido)pentanedioate |
| Disodium methotrexate |
| Disodium N-(4-(((2,4-diamino-6-pteridinyl)methyl)methylamino)benzoyl)-L-glutamate |
| DivK1c_000114 |
| DL-4-Amino-N10-methylpteroylglutamic acid hydrate |
| DL-Amethopterin hydrate |
| DSSTox_CID_822 |
| DSSTox_GSID_20822 |
| DSSTox_RID_75810 |
| DTXSID3037123 |
| DTXSID4020822 |
| EINECS 200-413-8 |
| EINECS 231-022-0 |
| EINECS 231-398-6 |
| EINECS 239-495-5 |
| 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 |
| FT-0698915 |
| g301 |
| Glutamic acid, N-(p-(((2,4-diamino-6-pteridinyl)methyl)methylamino)benzoyl)-, disodium salt, L-(+)- |
| Glutamic acid, N-(p-(((2,4-diamino-6-pteridinyl)methyl)methylamino)benzoyl)-, L- |
| Glutamic acid, N-(p-(((2,4-diamino-6-pteridinyl)methyl)methylamino)benzoyl)-, sodium salt |
| Glutamic acid, N-[p-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-, monosodium salt |
| 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, N-(4-(((2,4-diamino-6-pteridinyl)methyl)methylamino)benzoyl)-, sodium salt |
| 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 dinatrium |
| Methotrexat-Ebewe |
| methotrexate |
| 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 disodium |
| Methotrexate disodium salt |
| Methotrexate for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Methotrexate for system suitability, European Pharmacopoeia (EP) Reference Standard |
| Methotrexate Preservative Free |
| METHOTREXATE SODIUM PRESERVATIVE FREE |
| Methotrexate sodium salt |
| Methotrexate, European Pharmacopoeia (EP) Reference Standard |
| Methotrexate, L- |
| Methotrexate, monosodium salt |
| 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 |
| Mexate-Aq Preserved |
| MFCD00150847 |
| MLS000049968 |
| MLS001401431 |
| MLS002154208 |
| MolPort-003-665-521 |
| MolPort-006-118-727 |
| MPI-2505 |
| MPI-5004 |
| MTX |
| MTX disodium |
| MTX hydrate |
| MTX sodium |
| 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 |
| S509 |
| SC-19293 |
| SC-88579 |
| SCHEMBL12421860 |
| SCHEMBL3711 |
| SCHEMBL4135 |
| SCHEMBL48420 |
| SMP2_000020 |
| SMR000112001 |
| SMR000449324 |
| sodium (S)-2-(4-(((2,4-diaminopteridin-6-yl)methyl)(methyl)amino)benzamido)pentanedioate |
| Sodium L-(+)-methotrexate |
| Sodium methotrexate |
| Sodium N-(4-(((2,4-diamino-6-pteridinyl)methyl)methylamino)benzoyl)-L-glutamate |
| SODIUM N-[4-[[(2,4-DIAMINO-6-PTERIDINYL)METHYL]METHYLAMINO]BENZOYL]-L-GLUTAMATE |
| 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 |
| Trexall (TN) |
| Trexeron |
| Trixilem |
| UNII-3IG1E710ZN |
| UNII-87WE99J27Z |
| 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 sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abraxis Pharm | METHOTREXATE SODIUM | methotrexate sodium | INJECTABLE;INJECTION | 089263-001 | Jun 13, 1986 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Zydus Pharms | METHOTREXATE SODIUM | methotrexate sodium | TABLET;ORAL | 207812-001 | Jan 13, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Hikma | METHOTREXATE SODIUM | methotrexate sodium | TABLET;ORAL | 040054-001 | Aug 1, 1994 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Pharmacia And Upjohn | FOLEX | methotrexate sodium | INJECTABLE;INJECTION | 087695-001 | Apr 8, 1983 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Pharmachemie Bv | METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 040843-004 | Jan 11, 2010 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan | METHOTREXATE SODIUM | methotrexate sodium | TABLET;ORAL | 081235-001 | May 15, 1992 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Hospira | METHOTREXATE SODIUM | methotrexate sodium | INJECTABLE;INJECTION | 011719-010 | Dec 15, 2004 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for methotrexate sodium
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2726524 | Start Trial |
| European Patent Office | 2614814 | Start Trial |
| United Kingdom | 201200192 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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.
Copyright 2002-2020 thinkBiotech LLC
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2020 - 2021
NCE-1 Patent Challenge Dates 2020 - 2021
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2020 - 2021
NCE-1 Patent Challenge Dates 2020 - 2021
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.