METHOTREXATE - Generic Drug Details

What are the generic drug 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:	2,061
Patent Applications:	7,181
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

See drug sales revenues for METHOTREXATE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for METHOTREXATE

Dosage:

SOLUTION;SUBCUTANEOUS

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
Lucile Packard Children's Hospital Foundation	Phase 1/Phase 2
Stanford University	Phase 1/Phase 2
Pediatric Oncology Experimental Therapeutics Investigators' Consortium	Phase 1/Phase 2

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

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	204824-007	Mar 24, 2016		RX	Yes	Yes			Y
Lotus Pharm Co Ltd	METHOTREXATE SODIUM	methotrexate sodium	TABLET;ORAL	209787-001	Apr 23, 2021	AB	RX	No	No
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-006	Mar 24, 2016		RX	Yes	Yes			Y

Expired US Patents for METHOTREXATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-003	Oct 11, 2013
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-001	Oct 11, 2013
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-005	Nov 7, 2014

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

International Patents for METHOTREXATE

Country	Patent Number	Title	Estimated Expiration
Ukraine	95488	КОНЦЕНТРИРОВАННЫЙ РАСТВОР МЕТОТРЕКСАТА ДЛЯ ПОДКОЖНОГО ВВЕДЕНИЯ;КОНЦЕНТРОВАНИЙ РОЗЧИН МЕТОТРЕКСАТУ ДЛЯ ПІДШКІРНОГО ВВЕДЕННЯ (CONCENTRATED METHOTREXATE SOLUTION FOR SUBCUTANEOUS INTRODUCTION)
European Patent Office	3495009	INJECTEUR À JET DE SERINGUE PRÉREMPLIE (PREFILLED SYRINGE JET INJECTOR)
Japan	2016104214	危険有害性薬剤の注入システム (INJECTION SYSTEM OF DANGEROUS AND ADVERSE AGENT)