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Last Updated: November 22, 2024

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, Norbrook, Pharmachemie Usa, Accord Hlthcare, Eugia Pharma Speclts, Pharmachemie Bv, Rising, Sagent Pharms Inc, Sandoz, Bristol, Bristol Myers, Bristol Myers Squibb, Azurity, Alembic, Amneal Pharms, Barr, Daito, Duramed Pharms Barr, Elite Labs Inc, Eugia Pharma, Lotus Pharm Co Ltd, Mylan, Strides Pharma, Sun Pharm, and Zydus Pharms, and is included in fifty-three NDAs. There are six 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 three drug master file entries for methotrexate sodium. Twenty-eight suppliers are listed for this compound.

Summary for METHOTREXATE SODIUM
International Patents:3
US Patents:6
Tradenames:12
Applicants:30
NDAs:53
Drug Master File Entries: 3
Finished Product Suppliers / Packagers: 28
Raw Ingredient (Bulk) Api Vendors: 40
Clinical Trials: 36
Patent Applications: 7,601
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
AstraZenecaPhase 3
Seoul National University Bundang HospitalPhase 1
AbbViePhase 1

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
Mylan METHOTREXATE SODIUM methotrexate sodium TABLET;ORAL 081235-001 May 15, 1992 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Barr TREXALL methotrexate sodium TABLET;ORAL 040385-001 Mar 21, 2001 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Barr METHOTREXATE SODIUM methotrexate sodium TABLET;ORAL 081099-001 Oct 15, 1990 AB RX No 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

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