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Methotrexate sodium - Generic Drug Details
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What are the generic 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 Pharma Global, and Zydus Pharms Usa Inc, and is included in forty-seven NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are twenty drug master file entries for methotrexate sodium. Twenty-seven suppliers are listed for this compound.
Summary for methotrexate sodium
| US Patents: | 2 |
| Tradenames: | 12 |
| Applicants: | 24 |
| NDAs: | 47 |
| Drug Master File Entries: | 20 |
| Suppliers / Packagers: | 27 |
| Bulk Api Vendors: | 127 |
| Clinical Trials: | 20 |
| Patent Applications: | 7,349 |
| 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-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 |
| (S)-2-(4-(((2,4-Diaminopteridin-6-yl)methyl)(methyl)amino)benzamido)pentanedioic acid |
| (S)-2-(4-[(2,4-DIAMINO-PTERIDIN-6-YLMETHYL)-METHYL-AMINO]-BENZOYLAMINO)-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 |
| 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-N10-methylpteroyl glutamate sodium |
| 4-Amino-N10-methylpteroyl-L-glutamic acid |
| 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 (di-hydrochloride salt) |
| 7532-09-4 |
| A-2190 |
| A-Methopterin |
| A-Methpterin |
| AB02593 |
| Abitextrate |
| Abitrexate |
| Abitrexate (Methotrexate) |
| AC1L2R79 |
| ACT03341 |
| AI3-25299 |
| AJ-26587 |
| AK-77824 |
| AK340946 |
| AKOS016340329 |
| Amethopterin |
| Amethopterin L- |
| Amethopterine |
| An-PDN |
| Antifolan |
| Antifolan hydrate |
| ANW-72813 |
| AOB5585 |
| APC-2002 |
| Arbitrexate |
| BC202627 |
| BDBM18050 |
| BDBM66082 |
| BIDD:PXR0175 |
| Bio-0134 |
| Bio1_000486 |
| Bio1_000975 |
| Bio1_001464 |
| BR-77824 |
| BRD-K59456551-001-09-3 |
| Brimexate |
| C01937 |
| C20H22N8O5 |
| CAS-59-05-2 |
| CCG-35800 |
| CCRIS 1109 |
| CHEBI:44185 |
| CHEMBL34259 |
| cid_126941 |
| cid_165528 |
| CL 14377 |
| CL-14377 |
| CS-1732 |
| CTK1G9789 |
| D00142 |
| D02115 |
| D07ALU |
| D0D3DU |
| D0SV8E |
| DB00563 |
| DivK1c_000114 |
| DL-4-Amino-N10-methylpteroylglutamic acid hydrate |
| DL-Amethopterin hydrate |
| DR002811 |
| DSSTox_CID_822 |
| DSSTox_GSID_20822 |
| DSSTox_RID_75810 |
| DTXSID4020822 |
| EINECS 200-413-8 |
| EINECS 231-398-6 |
| EINECS 239-495-5 |
| EMT 25,299 |
| Emtexate |
| Emthexat |
| Emthexate |
| EU-0100020 |
| Fauldexato |
| FBOZXECLQNJBKD-ZDUSSCGKSA-N |
| Folex |
| Folex Pfs |
| 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, N-(p-(((2,4-diamino-6-pteridinyl)methyl)methylamino)benzoyl)-, sodium salt |
| Glutamic acid,4-diamino-6-pteridinyl)methyl] methylamino]benzoyl]-, L-(+)- |
| GTPL4674 |
| GTPL4815 |
| Hdmtx |
| HE357164 |
| HMS1568K12 |
| HMS2095K12 |
| HMS2233O18 |
| HMS3260C21 |
| 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-(+)-AMETHOPTERIN |
| 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-Glutamicacid, N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]- |
| L-METHOTREXATE |
| Lantarel |
| Ledertrexate |
| Lopac0_000020 |
| LP00020 |
| LS-249 |
| Lumexon |
| Maxtrex |
| MCULE-6523054194 |
| Medsatrexate |
| Metatrexan |
| Metex |
| Methoblastin |
| Methotextrate |
| Methotrate |
| Methotrexat |
| Methotrexat-Ebewe |
| methotrexate |
| Methotrexate 100mg |
| 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 hydrate |
| Methotrexate Lpf |
| 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; traceable to USP and PhEur |
| 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 |
| METHOTREXATEHYDRATE |
| Methotrexatum |
| Methotrexatum [INN-Latin] |
| Methoxtrexate |
| Methylaminopterin |
| Methylaminopterin hydrate |
| Methylaminopterin; MTX |
| METHYLAMINOPTERINE |
| Methylaminopterinum |
| Metolate |
| Metotressato |
| Metotressato [DCIT] |
| Metotrexato |
| Metotrexato [INN-Spanish] |
| Metrotex |
| Mexate |
| Mexate-Aq |
| Mexate-Aq Preserved |
| MFCD00150847 |
| MFCD28404646 |
| MLS000049968 |
| MLS001401431 |
| MLS002154208 |
| MolPort-003-665-521 |
| MolPort-028-616-821 |
| MPI-2505 |
| MPI-5004 |
| MTX |
| MTX hydrate |
| MTX sodium |
| N-(4-(((2,4-Diamino-6-pteridinyl)methyl)methylamino)benzoyl)-L-glutamicacid |
| N-(4-(((2,4-DIAMINO-6-PTERIDINYL)METHYL)METHYLAMINO)BENZOYL)L-GLUTAMIC ACID |
| N-(4-{[(2,4-Diaminopteridin-1-Ium-6-Yl)methyl](Methyl)amino}benzoyl)-L-Glutamic Acid |
| 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 |
| 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 |
| SC-88579 |
| SCHEMBL12421860 |
| SCHEMBL3711 |
| SCHEMBL4135 |
| SMP2_000020 |
| SMR000112001 |
| SMR000449324 |
| Sodium (S)-4-carboxy-4-(4-(((2,4-diaminopteridin-6-yl)methyl)(methyl)amino)benzamido)butanoate |
| Sodium L-(+)-methotrexate |
| 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 |
| TCMDC-125858 |
| Texate |
| Tocris-1230 |
| Tox21_110944 |
| Tox21_110944_1 |
| Tox21_300269 |
| Tox21_500020 |
| Tremetex |
| Trexall |
| Trexall (TN) |
| 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 sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 040767-001 | Apr 30, 2007 | AP | RX | No | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Hospira | METHOTREXATE LPF | methotrexate sodium | INJECTABLE;INJECTION | 011719-007 | Mar 31, 1982 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Hospira | METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 011719-009 | Apr 7, 1988 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Abraxis Pharm | METHOTREXATE SODIUM | methotrexate sodium | INJECTABLE;INJECTION | 088935-001 | Oct 11, 1985 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Abic | ABITREXATE | methotrexate sodium | INJECTABLE;INJECTION | 089354-001 | Jul 17, 1987 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Abraxis Pharm | METHOTREXATE SODIUM | methotrexate sodium | INJECTABLE;INJECTION | 088936-001 | Oct 11, 1985 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Hospira | METHOTREXATE PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 011719-013 | Apr 13, 2005 | DISCN | Yes | 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 |
see a sample report or, see our see our flat-rate plans
see a sample report or, see our see our flat-rate plans
International Patents for methotrexate sodium
| Country | Document Number | Estimated Expiration |
|---|---|---|
| United Kingdom | 201200192 | ➤ Sign Up |
| European Patent Office | 2614814 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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