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 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, Mylan, Pharmachemie Bv, Sagent Pharms Inc, Sandoz, Bristol, Bristol Myers, Bristol Myers Squibb, Azurity, Amneal Pharms, Barr, Daito, Duramed Pharms Barr, Eugia Pharma, Lotus Pharm Co Ltd, Strides Pharma, Sun Pharm, and Zydus Pharms, and is included in fifty-six NDAs. There are twenty-two 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. Three suppliers are listed for this compound.

Summary for methotrexate

International Patents:	89
US Patents:	22
Tradenames:	18
Applicants:	31
NDAs:	56
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	2,081
Patent Applications:	7,244
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for methotrexate
Drug Sales Revenues:	Drug sales revenues for methotrexate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for methotrexate
What excipients (inactive ingredients) are in methotrexate?	methotrexate excipients list
DailyMed Link:	methotrexate at DailyMed

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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: SOLUTION;SUBCUTANEOUS
Generic Entry Dates for methotrexate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
Alexion Pharmaceuticals, Inc.	Phase 4
Syndax Pharmaceuticals	Phase 1
University of California, Los Angeles	Phase 1

See all methotrexate clinical trials

Pharmacology for methotrexate

Drug Class	Folate Analog Metabolic Inhibitor
Mechanism of Action	Folic Acid Metabolism Inhibitors

Medical Subject Heading (MeSH) Categories for methotrexate

Abortifacient Agents, Nonsteroidal
Antimetabolites, Antineoplastic
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Nucleic Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for methotrexate

L01BA	Folic acid analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L04AX	Other immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for methotrexate

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Glossary

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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 PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824-009	May 31, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-002	Oct 11, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Shorla	JYLAMVO	methotrexate	SOLUTION;ORAL	212479-001	Nov 29, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Pharmacia And Upjohn	FOLEX	methotrexate sodium	INJECTABLE;INJECTION	087695-003	Apr 8, 1983		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Accord Hlthcare	METHOTREXATE SODIUM PRESERVATIVE FREE	methotrexate sodium	INJECTABLE;INJECTION	040768-001	Apr 30, 2007	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-001	Oct 11, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-007	Mar 24, 2016	⤷ Sign Up	⤷ Sign Up
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-001	Oct 11, 2013	⤷ Sign Up	⤷ Sign Up
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-004	Oct 11, 2013	⤷ Sign Up	⤷ Sign Up
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-001	Oct 11, 2013	⤷ Sign Up	⤷ Sign Up
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-002	Oct 11, 2013	⤷ Sign Up	⤷ Sign Up
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-008	Mar 24, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for methotrexate

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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

International Patents for methotrexate

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Country	Patent Number	Title	Estimated Expiration
Lithuania	3212237		⤷ Sign Up
South Korea	20120028294	HAZARDOUS AGENT INJECTION SYSTEM	⤷ Sign Up
Japan	2023103402	メトトレキサート製剤 (METHOTREXATE FORMULATION)	⤷ Sign Up
Portugal	1850892		⤷ Sign Up
Poland	2046332		⤷ Sign Up
European Patent Office	3495009	INJECTEUR À JET DE SERINGUE PRÉREMPLIE (PREFILLED SYRINGE JET INJECTOR)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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