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Last Updated: November 30, 2022

Methotrexate - Generic Drug Details


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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, Otter Pharms, Medexus, Cumberland Pharms, Abic, Pharmacia And Upjohn, Hospira, Fresenius Kabi Usa, Abraxis Pharm, Hikma, Norbrook, Pharmachemie Usa, Eugia Pharma Speclts, Mylan, Pharmachemie Bv, Sagent Pharms Inc, Sandoz Inc, Bristol, Bristol Myers, Bristol Myers Squibb, Azurity, Amneal Pharms, Barr, Duramed Pharms Barr, Eugia Pharma, Lotus Pharm Co Ltd, Strides Pharma, Sun Pharm, and Zydus Pharms, and is included in fifty-four NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Methotrexate has sixty-five 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
Takeda Development Center Americas, Inc.Phase 4
Institut National de la Santé Et de la Recherche Médicale, FrancePhase 2/Phase 3
GlycoMimetics IncorporatedPhase 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
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-001 Oct 11, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-007 Mar 24, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-003 Oct 11, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-004 Oct 11, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hikma METHOTREXATE SODIUM methotrexate sodium INJECTABLE;INJECTION 089341-001 Sep 16, 1986 AP RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 201530-001 Mar 29, 2012 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Azurity XATMEP methotrexate sodium SOLUTION;ORAL 208400-001 Apr 25, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 204824-001 Oct 11, 2013 See Plans and Pricing See Plans and Pricing
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-008 Mar 24, 2016 See Plans and Pricing See Plans and Pricing
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-008 Mar 24, 2016 See Plans and Pricing See Plans and Pricing
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-004 Oct 11, 2013 See Plans and Pricing See Plans and Pricing
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-007 Mar 24, 2016 See Plans and Pricing See Plans and Pricing
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-003 Oct 11, 2013 See Plans and Pricing See Plans and Pricing
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-005 Nov 7, 2014 See Plans and Pricing See Plans and Pricing
>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,, severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, psoralens and ultraviolet A (PUVA), and retinoids, 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

International Patents for methotrexate

Country Patent Number Title Estimated Expiration
Canada 2595730 INJECTEUR A SERINGUE PREREMPLIE ASSISTE D'UNE AIGUILLE (PREFILLED NEEDLE ASSISTED JET INJECTOR) See Plans and Pricing
Austria 14872 See Plans and Pricing
Israel 184765 PREFILLED NEEDLE ASSISTED JET INJECTOR See Plans and Pricing
Cyprus 1111159 See Plans and Pricing
China 101132820 Prefilled needle assisted jet injector See Plans and Pricing
South Korea 101260554 See Plans and Pricing
Japan 2016104214 危険有害性薬剤の注入システム (INJECTION SYSTEM OF DANGEROUS AND ADVERSE AGENT) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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