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Last Updated: August 3, 2020

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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 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, 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. Twenty-three suppliers are listed for this compound.

Summary for METHOTREXATE SODIUM
Recent Clinical Trials for METHOTREXATE SODIUM

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

SponsorPhase
Zhongda HospitalPhase 4
National Institute for Health Research, United KingdomPhase 4
University of OxfordPhase 4

See all METHOTREXATE SODIUM clinical trials

Pharmacology for METHOTREXATE SODIUM

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   Start Trial   Start Trial   Start Trial
Pharmachemie Bv METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 040843-001 Jan 11, 2010 AP RX No No   Start Trial   Start Trial   Start Trial
Barr TREXALL methotrexate sodium TABLET;ORAL 040385-004 Mar 21, 2001 RX No Yes   Start Trial   Start Trial   Start Trial
West-ward Pharms Int METHOTREXATE SODIUM methotrexate sodium INJECTABLE;INJECTION 089341-001 Sep 16, 1986 AP RX No 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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
Express Scripts
Medtronic
Dow
Colorcon

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