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Methotrexate sodiumis 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, Azurity, Amneal Pharms, Barr, Dava Pharms Inc, Duramed Pharms Barr, Eugia Pharma, Hikma, Mylan, Sun Pharm, and Zydus Pharms, and is included in forty-nine NDAs. There are four 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.
Recent Clinical Trials for methotrexate sodium
Identify potential brand extensions & 505(b)(2) entrants
|Zhongda Hospital||Phase 4|
|National Institute for Health Research, United Kingdom||Phase 4|
|University of Oxford||Phase 4|
Pharmacology for methotrexate sodium
|Drug Class||Folate Analog Metabolic Inhibitor |
|Mechanism of Action||Folic Acid Metabolism Inhibitors |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Sun Pharm||METHOTREXATE SODIUM||methotrexate sodium||TABLET;ORAL||201749-001||May 21, 2015||AB||RX||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|
|Sandoz Inc||METHOTREXATE SODIUM PRESERVATIVE FREE||methotrexate sodium||INJECTABLE;INJECTION||090029-001||Mar 31, 2009||AP||RX||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|
|Hospira||METHOTREXATE PRESERVATIVE FREE||methotrexate sodium||INJECTABLE;INJECTION||011719-014||Apr 13, 2005||DISCN||No||No||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|
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