➤ Get the DrugPatentWatch Daily Briefing

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

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Medtronic
Colorcon
Johnson and Johnson
Mallinckrodt

Last Updated: February 27, 2021

DrugPatentWatch Database Preview

Methotrexate - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic sources for methotrexate and what is the scope of freedom to operate?

Methotrexate is the generic ingredient in seventeen branded drugs marketed by Accord Hlthcare, Antares Pharma Inc, Medexus, Cumberland Pharms, Abic, Pharmacia And Upjohn, Hospira, Fresenius Kabi Usa, Abraxis Pharm, Norbrook, Pharmachemie Usa, West-ward Pharms Int, 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 fifty-three NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Methotrexate has seventy-seven patent family members in twenty-four countries.

There are twenty drug master file entries for methotrexate. Three suppliers are listed for this compound.

Drug Prices for methotrexate

See drug prices for methotrexate

Drug Sales Revenue Trends for methotrexate

See drug sales revenues for methotrexate

Recent Clinical Trials for methotrexate

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

SponsorPhase
National Cheng-Kung University HospitalPhase 1
Chang Gung Memorial HospitalPhase 1
National Taiwan University HospitalPhase 1

See all methotrexate clinical trials

Pharmacology for methotrexate

US Patents and Regulatory Information for methotrexate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira METHOTREXATE SODIUM methotrexate sodium INJECTABLE;INJECTION 011719-003 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Norbrook METHOTREXATE SODIUM methotrexate sodium INJECTABLE;INJECTION 088648-001 May 9, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-008 Mar 24, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
West-ward Pharms Int METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 089343-001 Sep 16, 1986 AP RX No Yes   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

Expired US Patents for methotrexate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-002 Oct 11, 2013   Start Trial   Start Trial
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-008 Mar 24, 2016   Start Trial   Start Trial
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-004 Oct 11, 2013   Start Trial   Start Trial
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-003 Oct 11, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Serving leading biopharmaceutical companies globally:

Moodys
Colorcon
Johnson and Johnson
AstraZeneca
Baxter
Harvard Business School

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.