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Last Updated: December 7, 2021

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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, Hikma Pharms, Norbrook, Pharmachemie Usa, Accord Hlthcare, Mylan, 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, Lotus Pharm Co Ltd, Sun Pharm, and Zydus Pharms, and is included in fifty 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-four suppliers are listed for this compound.

Summary for METHOTREXATE SODIUM
International Patents:3
US Patents:4
Tradenames:12
Applicants:26
NDAs:50
Drug Master File Entries: 20
Finished Product Suppliers / Packagers: 24
Raw Ingredient (Bulk) Api Vendors: 38
Clinical Trials: 23
Patent Applications: 6,943
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in METHOTREXATE SODIUM?METHOTREXATE SODIUM excipients list
DailyMed Link:METHOTREXATE SODIUM at DailyMed
Recent Clinical Trials for METHOTREXATE SODIUM

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

SponsorPhase
Zhongda HospitalPhase 3
Brown UniversityPhase 2
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
Lotus Pharm Co Ltd METHOTREXATE SODIUM methotrexate sodium TABLET;ORAL 209787-001 Apr 23, 2021 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sagent Pharms Inc METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 203407-003 Aug 9, 2018 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sagent Pharms Inc METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 203407-001 Aug 9, 2018 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Pharmachemie Bv METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 040843-004 Jan 11, 2010 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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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