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Last Updated: April 28, 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 patent protection?

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

Anatomical Therapeutic Chemical (ATC) Classes for methotrexate sodium

L01BA	Folic acid analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L04AX	Other immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

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
Abic	ABITREXATE	methotrexate sodium	INJECTABLE;INJECTION	089355-001	Jul 17, 1987		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pharmacia And Upjohn	FOLEX	methotrexate sodium	INJECTABLE;INJECTION	087695-001	Apr 8, 1983		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pharmachemie Bv	METHOTREXATE SODIUM PRESERVATIVE FREE	methotrexate sodium	INJECTABLE;INJECTION	040843-003	Feb 27, 2012		RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	METHOTREXATE PRESERVATIVE FREE	methotrexate sodium	INJECTABLE;INJECTION	011719-014	Apr 13, 2005		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan	METHOTREXATE SODIUM	methotrexate sodium	TABLET;ORAL	081235-001	May 15, 1992	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pharmachemie Bv	METHOTREXATE SODIUM PRESERVATIVE FREE	methotrexate sodium	INJECTABLE;INJECTION	040843-001	Jan 11, 2010	AP	RX	No	No	⤷ 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
Spain	2726524		⤷ Try a Trial
United Kingdom	201200192		⤷ Try a Trial
European Patent Office	2614814	Composition de méthotrexate (Methotrexate composition)	⤷ 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.