➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Merck
Moodys
Dow
Baxter
Colorcon
Express Scripts

Last Updated: January 17, 2021

DrugPatentWatch Database Preview

Methotrexate sodium - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic 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, Norbrook, Pharmachemie Usa, West-ward Pharms Int, Accord Hlthcare, Mylan Labs Ltd, Pharmachemie Bv, Sagent Pharms Inc, Sandoz Inc, Bristol, Bristol Myers, Bristol Myers Squibb, Azurity, Amneal Pharms, Barr, Dava Pharms Inc, Duramed Pharms Barr, Eugia Pharma, Hikma, Mylan, Sun Pharm, and Zydus Pharms, and is included in forty-nine NDAs. There are four 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 twenty drug master file entries for methotrexate sodium.

Summary for methotrexate sodium
Recent Clinical Trials for methotrexate sodium

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

SponsorPhase
Zhongda HospitalPhase 4
National Institute for Health Research, United KingdomPhase 4
University of OxfordPhase 4

See all methotrexate sodium clinical trials

Pharmacology for methotrexate sodium

US Patents and Regulatory Information for methotrexate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm METHOTREXATE SODIUM methotrexate sodium TABLET;ORAL 201749-001 May 21, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Pharmachemie Bv METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 040843-004 Jan 11, 2010 AP RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 090029-001 Mar 31, 2009 AP RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms METHOTREXATE SODIUM methotrexate sodium TABLET;ORAL 207812-001 Jan 13, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Hospira METHOTREXATE PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 011719-014 Apr 13, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
McKinsey
Boehringer Ingelheim
Merck
Dow

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.