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Last Updated: September 21, 2021

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Methotrexate - Generic Drug Details

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What are the generic sources for methotrexate and what is the scope of patent protection?

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, Hikma, Norbrook, Pharmachemie Usa, Mylan Labs Ltd, Pharmachemie Bv, Sagent Pharms Inc, Sandoz Inc, West-ward Pharms Int, Bristol, Bristol Myers, Bristol Myers Squibb, Azurity, Amneal Pharms, Barr, Dava Pharms Inc, Duramed Pharms Barr, Eugia Pharma, Lotus Pharm Co Ltd, Mylan, Sun Pharm, and Zydus Pharms, and is included in fifty-four NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Methotrexate has sixty-four 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

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Drug Sales Revenue Trends for methotrexate

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Recent Clinical Trials for methotrexate

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

SponsorPhase
French Vasculitis Study GroupPhase 3
URC-CIC Paris Descartes Necker CochinPhase 3
Milton S. Hershey Medical CenterPhase 1/Phase 2

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
Medexus RASUVO methotrexate SOLUTION;SUBCUTANEOUS 205776-004 Jul 10, 2014 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-008 Mar 24, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Fresenius Kabi Usa METHOTREXATE PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 040266-001 Feb 26, 1999 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Antares Pharma Inc OTREXUP PFS methotrexate SOLUTION;SUBCUTANEOUS 204824-012 May 31, 2017 DISCN Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-008 Mar 24, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-001 Oct 11, 2013 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-002 Oct 11, 2013 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 204824-004 Oct 11, 2013 ⤷  Try it Free ⤷  Try it Free
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-004 Oct 11, 2013 ⤷  Try it Free ⤷  Try it Free
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-001 Oct 11, 2013 ⤷  Try it Free ⤷  Try it Free
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-003 Oct 11, 2013 ⤷  Try it Free ⤷  Try it Free
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-005 Nov 7, 2014 ⤷  Try it Free ⤷  Try it Free
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-003 Oct 11, 2013 ⤷  Try it Free ⤷  Try it Free
Antares Pharma Inc OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-007 Mar 24, 2016 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Moodys
Johnson and Johnson
Colorcon
McKesson
Express Scripts

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.