METHOTREXATE SODIUM PRESERVATIVE FREE Drug Patent Profile

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Methotrexate Sodium Preservative Free is a drug marketed by Accord Hlthcare, Eugia Pharma Speclts, Hikma, Hospira, Pharmachemie Bv, Rising, Sagent Pharms Inc, and Sandoz. and is included in thirteen NDAs.

The generic ingredient in METHOTREXATE SODIUM PRESERVATIVE FREE is methotrexate sodium. There are twenty drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.

A generic version of METHOTREXATE SODIUM PRESERVATIVE FREE was approved as methotrexate sodium by HIKMA on September 16^th, 1986.

US Patents:	0
Applicants:	8
NDAs:	13
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	1
Patent Applications:	4,433
DailyMed Link:	METHOTREXATE SODIUM PRESERVATIVE FREE at DailyMed

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Cooperative Study Group A for Hematology	Phase 3

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

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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
Accord Hlthcare	METHOTREXATE SODIUM PRESERVATIVE FREE	methotrexate sodium	INJECTABLE;INJECTION	040716-001	Apr 30, 2007	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sagent Pharms Inc	METHOTREXATE SODIUM PRESERVATIVE FREE	methotrexate sodium	INJECTABLE;INJECTION	203407-003	Aug 9, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma Speclts	METHOTREXATE SODIUM PRESERVATIVE FREE	methotrexate sodium	INJECTABLE;INJECTION	201529-004	Mar 29, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma Speclts	METHOTREXATE SODIUM PRESERVATIVE FREE	methotrexate sodium	INJECTABLE;INJECTION	201529-001	Mar 29, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	METHOTREXATE SODIUM PRESERVATIVE FREE	methotrexate sodium	INJECTABLE;INJECTION	011719-012	Apr 13, 2005	AP	RX	Yes	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
Hikma	METHOTREXATE SODIUM PRESERVATIVE FREE	methotrexate sodium	INJECTABLE;INJECTION	040632-001	Aug 12, 2005		RX	No	Yes	⤷ 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