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:	35
Patent Applications:	7,638
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
Seoul National University Bundang Hospital	Phase 1
Boston Children's Hospital	Phase 1
Servier	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
Bristol	MEXATE	methotrexate sodium	INJECTABLE;INJECTION	086358-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharmacia And Upjohn	FOLEX PFS	methotrexate sodium	INJECTABLE;INJECTION	089180-001	Jan 3, 1986		DISCN	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
Mylan	METHOTREXATE SODIUM	methotrexate sodium	TABLET;ORAL	081235-001	May 15, 1992	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

International Patents for methotrexate sodium

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Country	Patent Number	Title	Estimated Expiration
United Kingdom	201200192		⤷ Sign Up
Spain	2726524		⤷ Sign Up
European Patent Office	2614814	Composition de méthotrexate (Methotrexate composition)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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