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, 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

Sponsor	Phase
AstraZeneca	Phase 3
Seoul National University Bundang Hospital	Phase 1
Boston Children's Hospital	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
Pharmacia And Upjohn	FOLEX PFS	methotrexate sodium	INJECTABLE;INJECTION	089180-001	Jan 3, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	METHOTREXATE SODIUM	methotrexate sodium	TABLET;ORAL	210040-001	Dec 22, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	METHOTREXATE SODIUM PRESERVATIVE FREE	methotrexate sodium	INJECTABLE;INJECTION	089340-001	Sep 16, 1986	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Barr	TREXALL	methotrexate sodium	TABLET;ORAL	040385-003	Mar 21, 2001		RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	METHOTREXATE SODIUM PRESERVATIVE FREE	methotrexate sodium	INJECTABLE;INJECTION	040632-001	Aug 12, 2005		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sagent Pharms Inc	METHOTREXATE SODIUM PRESERVATIVE FREE	methotrexate sodium	INJECTABLE;INJECTION	203407-002	Aug 9, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharmacia And Upjohn	FOLEX PFS	methotrexate sodium	INJECTABLE;INJECTION	081242-001	Aug 23, 1991		DISCN	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
Spain	2726524		⤷ Sign Up
United Kingdom	201200192		⤷ Sign Up
European Patent Office	2614814	Composition de méthotrexate (Methotrexate composition)	⤷ Sign Up
European Patent Office	2614814		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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