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, 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.

Summary for methotrexate

International Patents:	89
US Patents:	23
Tradenames:	18
Applicants:	34
NDAs:	58
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	2,081
Patent Applications:	7,320
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	methotrexate	SOLUTION;SUBCUTANEOUS	204824-008	Mar 24, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Otter Pharms	OTREXUP PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824-011	May 31, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-005	Nov 7, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-007	Mar 24, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sandoz	METHOTREXATE SODIUM PRESERVATIVE FREE	methotrexate sodium	INJECTABLE;INJECTION	090029-001	Mar 31, 2009	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Azurity	XATMEP	methotrexate sodium	SOLUTION;ORAL	208400-001	Apr 25, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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	204824-002	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	204824-002	Oct 11, 2013	⤷ Sign Up	⤷ Sign Up
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-003	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	204824-002	Oct 11, 2013	⤷ Sign Up	⤷ Sign Up
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-001	Oct 11, 2013	⤷ 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
Cyprus	1125033		⤷ Sign Up
Japan	2016104214	危険有害性薬剤の注入システム (INJECTION SYSTEM OF DANGEROUS AND ADVERSE AGENT)	⤷ Sign Up
South Korea	20090079876	CONCENTRATED METHOTREXATE SOLUTIONS	⤷ Sign Up
Spain	2908447		⤷ Sign Up
China	116747190	甲氨蝶呤制剂 (Methotrexate formulations)	⤷ Sign Up
Austria	14872		⤷ Sign Up
United Kingdom	2531940	Methotrexate formulation	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.