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Last Updated: October 6, 2022

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, Mylan, Pharmachemie Bv, Sagent Pharms Inc, Sandoz Inc, Bristol, Bristol Myers, Bristol Myers Squibb, Azurity, Amneal Pharms, Barr, Duramed Pharms Barr, Eugia Pharma, Lotus Pharm Co Ltd, Strides Pharma, Sun Pharm, and Zydus Pharms, and is included in fifty NDAs. There are five 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-five suppliers are listed for this compound.

Summary for methotrexate sodium
International Patents:3
US Patents:5
Tradenames:12
Applicants:26
NDAs:50
Drug Master File Entries: 3
Finished Product Suppliers / Packagers: 25
Raw Ingredient (Bulk) Api Vendors: 51
Clinical Trials: 33
Patent Applications: 7,471
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
ServierPhase 1
AbbViePhase 1
Andrew E. PlacePhase 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
Sandoz Inc METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 090039-002 Mar 31, 2009 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Accord Hlthcare METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 040767-001 Apr 30, 2007 AP RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abraxis Pharm METHOTREXATE SODIUM methotrexate sodium INJECTABLE;INJECTION 088935-001 Oct 11, 1985 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abraxis Pharm METHOTREXATE SODIUM methotrexate sodium INJECTABLE;INJECTION 089323-001 Jun 13, 1986 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abraxis Pharm METHOTREXATE SODIUM methotrexate sodium INJECTABLE;INJECTION 089263-001 Jun 13, 1986 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abraxis Pharm METHOTREXATE SODIUM methotrexate sodium INJECTABLE;INJECTION 089322-001 Jun 13, 1986 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.