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Last Updated: April 24, 2024

Methotrexate sodium - Generic Drug Details

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What are the generic drug 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, Bristol, Bristol Myers, Bristol Myers Squibb, Azurity, Amneal Pharms, Barr, Daito, Duramed Pharms Barr, Eugia Pharma, Lotus Pharm Co Ltd, Strides Pharma, Sun Pharm, and Zydus Pharms, and is included in fifty-one 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-four suppliers are listed for this compound.

Summary for methotrexate sodium

International Patents:	3
US Patents:	5
Tradenames:	12
Applicants:	27
NDAs:	51
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	34
Patent Applications:	7,598
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

Sponsor	Phase
Servier	Phase 1
AbbVie	Phase 1
Andrew E. Place	Phase 1

See all methotrexate sodium clinical trials

Pharmacology for methotrexate sodium

Drug Class	Folate Analog Metabolic Inhibitor
Mechanism of Action	Folic Acid Metabolism Inhibitors

US Patents and Regulatory Information for methotrexate sodium

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmachemie Bv	METHOTREXATE SODIUM PRESERVATIVE FREE	methotrexate sodium	INJECTABLE;INJECTION	040843-004	Jan 11, 2010	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	METHOTREXATE SODIUM	methotrexate sodium	TABLET;ORAL	207812-001	Jan 13, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	METHOTREXATE SODIUM	methotrexate sodium	INJECTABLE;INJECTION	011719-010	Dec 15, 2004	AP	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for methotrexate sodium

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Country	Patent Number	Title	Estimated Expiration
United Kingdom	201200192		⤷ Try a Trial
European Patent Office	2614814	Composition de méthotrexate (Methotrexate composition)	⤷ Try a Trial
Spain	2726524		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated 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.