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Last Updated: December 14, 2024

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 eighteen branded drugs marketed by Accord Hlthcare, Shorla, Otter Pharms, Medexus, Nordic Grp, Abic, Pharmacia And Upjohn, Hospira, Fresenius Kabi Usa, Abraxis Pharm, Hikma, Norbrook, Pharmachemie Usa, Eugia Pharma Speclts, Pharmachemie Bv, Rising, Sagent Pharms Inc, Sandoz, Bristol, Bristol Myers, Bristol Myers Squibb, Azurity, Alembic, Amneal Pharms, Barr, Daito, Duramed Pharms Barr, Elite Labs Inc, Eugia Pharma, Lotus Pharm Co Ltd, Mylan, Strides Pharma, Sun Pharm, and Zydus Pharms, and is included in fifty-eight NDAs. There are twenty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Methotrexate has eighty-nine patent family members in twenty-eight countries.

There are twenty drug master file entries for methotrexate. Four 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

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for methotrexate
Generic Entry Dates for methotrexate*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS
Generic Entry Dates for methotrexate*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for methotrexate

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

SponsorPhase
Alexion Pharmaceuticals, Inc.Phase 4
Syndax PharmaceuticalsPhase 1
University of California, Los AngelesPhase 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
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-002 Oct 11, 2013 RX Yes Yes 8,021,335 ⤷  Subscribe Y ⤷  Subscribe
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-002 Oct 11, 2013 RX Yes Yes 8,562,564 ⤷  Subscribe Y ⤷  Subscribe
Fresenius Kabi Usa METHOTREXATE PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 040265-001 Feb 26, 1999 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Otter Pharms OTREXUP PFS methotrexate SOLUTION;SUBCUTANEOUS 204824-010 May 31, 2017 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>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
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-004 Oct 11, 2013 7,776,015 ⤷  Subscribe
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-003 Oct 11, 2013 6,746,429 ⤷  Subscribe
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-007 Mar 24, 2016 RE44847 ⤷  Subscribe
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-006 Mar 24, 2016 RE44847 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for methotrexate

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Nordic Group B.V. Nordimet methotrexate EMEA/H/C/003983
Nordimet is indicated for the treatment of:active rheumatoid arthritis in adult patients,polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate,moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and severe psoriatic arthritis in adult patients, induction of remission in moderate steroid-dependent Crohn's disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate.
Authorised no no no 2016-08-18
Therakind (Europe) Limited Jylamvo methotrexate EMEA/H/C/003756
In rheumatological and dermatological diseasesActive rheumatoid arthritis in adult patients.Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate.Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients.In oncologyMaintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over.
Authorised no no no 2017-03-29
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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