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Last Updated: July 29, 2021

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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 patent protection?

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, Lotus Pharm Co Ltd, Mylan, 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-five suppliers are listed for this compound.

Summary for methotrexate sodium
International Patents:3
US Patents:4
Tradenames:12
Applicants:27
NDAs:50
Drug Master File Entries: 20
Finished Product Suppliers / Packagers: 25
Raw Ingredient (Bulk) Api Vendors: 36
Clinical Trials: 23
Patent Applications: 7,047
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 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
Pharmacia And Upjohn FOLEX methotrexate sodium INJECTABLE;INJECTION 087695-001 Apr 8, 1983 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Pharmacia And Upjohn FOLEX methotrexate sodium INJECTABLE;INJECTION 087695-003 Apr 8, 1983 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Abic ABITREXATE methotrexate sodium INJECTABLE;INJECTION 089354-001 Jul 17, 1987 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Azurity XATMEP methotrexate sodium SOLUTION;ORAL 208400-001 Apr 25, 2017 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hospira METHOTREXATE SODIUM methotrexate sodium INJECTABLE;INJECTION 011719-010 Dec 15, 2004 AP RX Yes Yes ⤷  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:

McKesson
Medtronic
Express Scripts
Boehringer Ingelheim
McKinsey
Dow

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