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Methotrexate sodium - Generic Drug Details
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What are the generic drug sources for methotrexate sodium and what is the scope of methotrexate sodium 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, 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-seven NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Methotrexate sodium has two patent family members in two countries.
There are twenty drug master file entries for methotrexate sodium. Twenty-six suppliers are listed for this compound.
Summary for methotrexate sodium
| International Patents: | 2 |
| US Patents: | 3 |
| Tradenames: | 12 |
| Applicants: | 24 |
| NDAs: | 47 |
| Drug Master File Entries: | 20 |
| Suppliers / Packagers: | 26 |
| Bulk Api Vendors: | 142 |
| Clinical Trials: | 21 |
| Patent Applications: | 7,299 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | methotrexate sodium at DailyMed |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hospira | METHOTREXATE SODIUM | methotrexate sodium | INJECTABLE;INJECTION | 011719-005 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Abic | ABITREXATE | methotrexate sodium | INJECTABLE;INJECTION | 089356-001 | Jul 17, 1987 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Norbrook | METHOTREXATE SODIUM | methotrexate sodium | INJECTABLE;INJECTION | 088648-001 | May 9, 1986 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Hospira | METHOTREXATE PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 011719-014 | Apr 13, 2005 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Hospira | METHOTREXATE SODIUM | methotrexate sodium | INJECTABLE;INJECTION | 011719-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| >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 |
|---|---|---|
| United Kingdom | 201200192 | ➤ Sign Up |
| European Patent Office | 2614814 | ➤ Sign Up |
| >Country | >Patent Number | >Estimated Expiration |
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ISSN: 2162-2639
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.