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, 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

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
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	XATMEP	methotrexate sodium	SOLUTION;ORAL	208400-001	Apr 25, 2017		RX	Yes	Yes			Y
Otter Pharms	OTREXUP PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824-014	May 31, 2017		DISCN	Yes	No
Hospira	METHOTREXATE SODIUM	methotrexate sodium	INJECTABLE;INJECTION	011719-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-005	Nov 7, 2014		DISCN	Yes	No			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	204824-001	Oct 11, 2013
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-001	Oct 11, 2013

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
Japan	5683810
Japan	2016104214	危険有害性薬剤の注入システム (INJECTION SYSTEM OF DANGEROUS AND ADVERSE AGENT)
Japan	2012521224
Canada	3002493	FORMULATION DE METHOTREXATE (METHOTREXATE FORMULATION)

METHOTREXATE Market Analysis and Financial Projection Experimental

Methotrexate Drug Market: Dynamics and Financial Trajectory

Market Overview

The methotrexate drug market is poised for significant growth over the next decade, driven by several key factors. Here’s a detailed look at the market dynamics and financial trajectory of methotrexate.

Market Size and Growth Projections

• The methotrexate drug market was valued at approximately USD 621.3 million in 2024 and is projected to reach USD 1,058 million by 2034, growing at a Compound Annual Growth Rate (CAGR) of 5.5% during this period[1].
• Another report estimates the market size to be around USD 590.4 million in 2023, with a forecasted growth to USD 776.5 million by 2031 at a CAGR of 3.1%[4].

Key Drivers of Growth

Increasing Prevalence of Target Diseases

The global burden of diseases such as rheumatoid arthritis, psoriasis, and various types of cancer is on the rise. This increasing prevalence is a major driver for the demand of methotrexate, which is widely used to treat these conditions[5].

Technological Advancements and Personalized Medicine

Advancements in medication delivery systems and formulations are improving patient outcomes and adherence. The demand for personalized medicine is also fostering the growth of the methotrexate market[3].

Aging Population and Healthcare Expenditure

An aging population is more prone to cancer and autoimmune diseases, which in turn increases the demand for methotrexate. Rising healthcare expenditure, especially in developing nations, is also contributing to the market growth[4].

Research and Development

Ongoing research and development activities aimed at discovering new therapeutic applications and creating innovative formulations or combination medicines are expected to propel the market forward[5].

Market Segmentation

Indication

• The methotrexate market is segmented based on indications such as psoriasis, rheumatoid arthritis, cancer, and other diseases. The cancer segment is forecasted to show robust growth, reaching USD 263.4 million by 2032[3].
• Rheumatoid arthritis is another significant segment, expected to register a CAGR of 5.3% from 2024 to 2034[1].

Drug Type

• The market is bifurcated into branded and generic methotrexate drugs. The branded segment accounted for USD 346.6 million in 2023[3].

Drug Form

• Methotrexate is available in various forms such as tablets, liquids, and injectables. The tablet segment is forecasted to reach USD 375.5 million by 2032[3].

Route of Administration

• The market is segmented based on the route of administration, including oral, subcutaneous, intramuscular, and intravenous. The oral segment accounted for USD 268.6 million in 2023[3].

Distribution Channel

• The distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies accounted for USD 248.6 million in 2023[3].

Regional Analysis

United States

• The U.S. methotrexate market is expected to grow at a CAGR of 5.7% from 2024 to 2034. Rising concerns about cancer and autoimmune diseases, along with expanding healthcare expenditure and a shift toward value-based care, are driving this growth[1].

China

• The Chinese market is projected to grow at a CAGR of 5.9% during the forecast period. This growth is attributed to increasing healthcare expenditure and technological advancements[1].

Japan and South Korea

• Japan and South Korea are also expected to witness significant growth, with Japan’s market growing at a CAGR of 7.0% and South Korea’s at 6.9% from 2024 to 2034[1].

Europe

• The UK and other European countries are expected to experience promising growth from 2024 to 2032, driven by increased research and development activities and the presence of refined medical facilities[3].

Financial Performance and Investment

Revenue and Net Income

• Companies in the methotrexate market are generating significant revenues. For example, Cumberland Pharmaceuticals reported net revenues of $8.1 million for the third quarter of 2021, with specific products like Kristalose® and Vibativ® contributing substantially to these revenues[2].

Research and Development Investments

• Companies are investing heavily in research and development to develop new and improved methotrexate products. This investment is crucial for maintaining market competitiveness and driving innovation[1].

Challenges and Restraints

Pricing and Reimbursement Policies

• The availability and cost of methotrexate injections are major restraining factors. Pricing and reimbursement policies, which vary by country, can make it difficult for manufacturers to enter the market and gain traction[1].

Competitive Landscape

• The competition in the methotrexate market is expected to intensify due to increasing demand and the entry of new players. This competition is driving companies to invest more in research and development to stay competitive[1].

Key Takeaways

• The methotrexate drug market is expected to grow significantly, driven by the increasing prevalence of target diseases, technological advancements, and an aging population.
• The market is segmented based on indication, drug type, drug form, route of administration, and distribution channel.
• Regional markets, particularly in the U.S., China, Japan, and South Korea, are expected to show robust growth.
• Companies are investing heavily in research and development to maintain competitiveness.
• Pricing and reimbursement policies remain a significant challenge for market growth.

FAQs

Q: What is the projected market size of the methotrexate drug market by 2034?

A: The methotrexate drug market is projected to reach USD 1,058 million by 2034[1].

Q: What are the key drivers of the methotrexate market growth?

A: The key drivers include the increasing prevalence of target diseases, technological advancements, an aging population, and rising healthcare expenditure[3][4].

Q: Which segment of the methotrexate market is expected to show robust growth?

A: The cancer segment is forecasted to show robust growth, reaching USD 263.4 million by 2032[3].

Q: What are the major challenges facing the methotrexate market?

A: The major challenges include pricing and reimbursement policies, which vary by country and can restrict market access[1].

Q: Which regions are expected to witness significant growth in the methotrexate market?

A: The U.S., China, Japan, and South Korea are expected to witness significant growth in the methotrexate market[1].

Sources

1. Future Market Insights: Methotrexate Drug Market Size, Share, Trends & Forecast by 2034.
2. Cumberland Pharmaceuticals: Cumberland Pharmaceuticals Reports Third Quarter 2021 Financial Results & Company Update.
3. Global Market Insights: Methotrexate Drugs Market Size & Share Report, 2024 – 2032.
4. Market Research Intellect: Methotrexate Drugs Market Size, Share & Growth by 2031.
5. Data Bridge Market Research: Methotrexate Injection Market Size, Value & Opportunities By 2030.