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OmniRx › Tools › Generic competition check › Methotrexate Sodium

Generic competition · all medicines · read 12 November 2026

Is there a generic of Methotrexate Sodium, and who makes it?

Methotrexate Sodium appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 13 generic makers listed as marketed across them. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came 1 years after the first brand approval. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Methotrexate Sodium3 dosage-form groups in the Orange Book
13generic makers listed
  1. Methotrexate Sodium appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 13 generic makers listed as marketed across them.
  2. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
  3. Where both are dated, the first generic approval came 1 years after the first brand approval.
  4. Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

Injectable, Injection

Four or more generic makers listed

Brand listed as marketed: Methotrexate Sodium and Methotrexate Sodium Preservative Free. 8 generic makers with 24 generic products listed as marketed; the first generic approval is dated 8 April 1983.

1980198519901995200020052010201520202025203008brand 1982Hikma Pharmaceuticals Usa Inc, first approval 16 September 1986Fresenius Kabi Usa Llc, first approval 26 February 1999Accord Healthcare Inc, first approval 30 April 2007Pharmachemie Bv, first approval 11 January 2010Eugia Pharma Specialities Ltd, first approval 29 March 2012Sagent Pharmaceuticals Inc, first approval 9 August 2018Alembic Pharmaceuticals Ltd, first approval 15 April 2026Hetero Labs Ltd Unit Vi, first approval 30 April 2026data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Hikma Pharmaceuticals Usa Inc16 September 19865
Fresenius Kabi Usa Llc26 February 19992
Accord Healthcare Inc30 April 20073
Pharmachemie Bv11 January 20104
Eugia Pharma Specialities Ltd29 March 20124
Sagent Pharmaceuticals Inc9 August 20183
Alembic Pharmaceuticals Ltd15 April 20262
Hetero Labs Ltd Unit Vi30 April 20261

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Tablet, Oral

Four or more generic makers listed

Every brand product here is listed as discontinued. 9 generic makers with 13 generic products listed as marketed; the first generic approval is dated 15 October 1990.

19901995200020052010201520202025203009Barr Laboratories Inc, first approval 15 October 1990Mylan Pharmaceuticals Inc, first approval 15 May 1992Hikma Pharmaceuticals Usa Inc, first approval 1 August 1994Sun Pharmaceutical Industries Ltd, first approval 21 May 2015Zydus Pharmaceuticals Usa Inc, first approval 13 January 2017Accord Healthcare Inc, first approval 24 January 2020Eugia Pharma Specialities Ltd, first approval 30 January 2020Elite Laboratories Inc, first approval 16 May 2024Alembic Pharmaceuticals Ltd, first approval 3 June 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Barr Laboratories Inc15 October 19905
Mylan Pharmaceuticals Inc15 May 19921
Hikma Pharmaceuticals Usa Inc1 August 19941
Sun Pharmaceutical Industries Ltd21 May 20151
Zydus Pharmaceuticals Usa Inc13 January 20171
Accord Healthcare Inc24 January 20201
Eugia Pharma Specialities Ltd30 January 20201
Elite Laboratories Inc16 May 20241
Alembic Pharmaceuticals Ltd3 June 20241

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Solution, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Xatmep. No generic is listed as marketed.

2015202020252030203501brand 2017data datePatent 10231927 listed to expire 2 January 2033Patent 11116724 listed to expire 2 January 2033Patent 11969503 listed to expire 2 January 2033Patent 12396947 listed to expire 2 January 2033Patent 10610485 listed to expire 2 January 2033Patent 9855215 listed to expire 2 January 2033Patent 9259427 listed to expire 2 January 2033
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 2 January 2033Patent 10231927
  • 2 January 2033Patent 11116724
  • 2 January 2033Patent 11969503 drug product
  • 2 January 2033Patent 12396947 drug product
  • 2 January 2033Patent 10610485 drug product
  • 2 January 2033Patent 9855215 drug product
  • 2 January 2033Patent 9259427 drug product

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.