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Last Updated: December 7, 2021

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METHOTREXATE Drug Patent Profile


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When do Methotrexate patents expire, and what generic alternatives are available?

Methotrexate is a drug marketed by Accord Hlthcare, Hospira, Fresenius Kabi Usa, Abraxis Pharm, Hikma Pharms, Norbrook, Pharmachemie Usa, Akorn, Amneal Pharms, Barr, Dava Pharms Inc, Duramed Pharms Barr, Eugia Pharma, Lotus Pharm Co Ltd, Mylan, Sun Pharm, Zydus Pharms, Mylan Labs Ltd, Pharmachemie Bv, Sagent Pharms Inc, and Sandoz Inc. and is included in thirty-nine NDAs.

The generic ingredient in METHOTREXATE is calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate. There are two hundred and eighty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate profile page.

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
Hikma Pharms METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 040632-001 Aug 12, 2005 RX No Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Eugia Pharma METHOTREXATE SODIUM methotrexate sodium TABLET;ORAL 210454-001 Jan 30, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan Labs Ltd METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 201529-003 Mar 29, 2012 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sandoz Inc METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 090039-002 Mar 31, 2009 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hospira METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 011719-012 Apr 13, 2005 AP RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan Labs Ltd METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 201529-004 Mar 29, 2012 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sagent Pharms Inc METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 203407-003 Aug 9, 2018 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  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

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