METHOTREXATE SODIUM - Generic Drug Details

What are the generic sources for methotrexate sodium and what is the scope of freedom to operate?

Methotrexate sodium is the generic ingredient in twelve branded drugs marketed by Abic, Pharmacia And Upjohn, Hospira, Fresenius Kabi Usa, Abraxis Pharm, Hikma, Norbrook, Pharmachemie Usa, Accord Hlthcare, 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-three NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Methotrexate sodium has three patent family members in three countries.

There are three drug master file entries for methotrexate sodium. Twenty-eight suppliers are listed for this compound.

Summary for METHOTREXATE SODIUM

International Patents:	3
US Patents:	6
Tradenames:	12
Applicants:	30
NDAs:	53
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	36
Patent Applications:	7,530
What excipients (inactive ingredients) are in METHOTREXATE SODIUM?	METHOTREXATE SODIUM excipients list
DailyMed Link:	METHOTREXATE SODIUM at DailyMed

Recent Clinical Trials for METHOTREXATE SODIUM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
AstraZeneca	Phase 3
Seoul National University Bundang Hospital	Phase 1
University of Colorado, Denver	Phase 1

See all METHOTREXATE SODIUM clinical trials

Pharmacology for METHOTREXATE SODIUM

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

Anatomical Therapeutic Chemical (ATC) Classes for METHOTREXATE SODIUM

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 SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	METHOTREXATE PRESERVATIVE FREE	methotrexate sodium	INJECTABLE;INJECTION	011719-014	Apr 13, 2005		DISCN	Yes	No
Barr	TREXALL	methotrexate sodium	TABLET;ORAL	040385-004	Mar 21, 2001		RX	No	Yes
Azurity	XATMEP	methotrexate sodium	SOLUTION;ORAL	208400-001	Apr 25, 2017		RX	Yes	Yes	9,259,427		Y

International Patents for METHOTREXATE SODIUM

Country	Patent Number	Title	Estimated Expiration
United Kingdom	201200192
European Patent Office	2614814
European Patent Office	2614814	Composition de méthotrexate (Methotrexate composition)

METHOTREXATE SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Methotrexate Sodium

Introduction

Methotrexate sodium is a widely used medication in the treatment of various conditions, including cancer, autoimmune diseases, and severe psoriasis. This article delves into the market dynamics and financial trajectory of methotrexate sodium, providing insights into its current market size, growth prospects, and key drivers.

Current Market Size

As of 2023, the global market for methotrexate sodium was estimated to be worth approximately $95 million[1]. In a broader context, the global methotrexate drugs market, which includes various forms of methotrexate, was valued at $0.52 billion in 2023[3].

Forecasted Market Size

The methotrexate sodium market is projected to grow significantly over the next few years. By 2030, the market is forecasted to reach a size of $141.7 million, with a Compound Annual Growth Rate (CAGR) of 5.8% during the period from 2024 to 2030[1].

For the broader methotrexate drugs market, projections indicate a growth to $0.66 billion by 2032, with a CAGR of 2.7%[3]. Another report suggests that the methotrexate drugs market will exceed $846.99 million by 2037, registering a CAGR of over 2.9% during the forecast period[4].

Key Drivers

Several factors are driving the growth of the methotrexate sodium market:

Increasing Applications in Cancer Treatment

Methotrexate is a crucial chemotherapy agent used in the treatment of various cancers, including acute lymphoblastic leukemia. The rising incidence of cancer globally is a significant driver for this market[2][4].

Autoimmune Diseases

The drug is also widely used in the treatment of autoimmune diseases such as rheumatoid arthritis, juvenile rheumatoid arthritis, and lupus. Approximately 60% of people with rheumatoid arthritis are currently taking methotrexate, which is the recommended first-line treatment according to the American College of Rheumatology[4].

Psoriasis

Severe psoriasis is another condition treated with methotrexate, contributing to the demand for this medication[2].

Regional Market Dynamics

North America

The North American market is expected to hold a significant share of the global methotrexate drugs market. Factors such as high adoption of innovative technologies, higher healthcare expenditures, and the availability of reimbursement policies are driving growth in this region. For instance, the launch of new products like Cumberland Pharmaceuticals Inc.'s RediTrex injection has contributed to the regional growth[4].

Asia-Pacific

The Asia-Pacific region is also expected to see notable growth due to increasing awareness of different medical modalities and a surging number of patients requiring medical treatments, including those for autoimmune diseases and cancer[4].

Competitive Landscape

The methotrexate sodium market is competitive, with several key players:

• Elite Pharmaceuticals: Recently launched generic methotrexate sodium 2.5 mg tablets, entering a market segment with approximately $63 million in annual U.S. sales[2].
• Qualitest (DAVA Pharmaceuticals): One of the companies operating in the methotrexate sodium market[1].
• Roxane Laboratories Inc., Mylan Pharmaceuticals Inc., Teva USA (Barr Laboratories), and STADA Pharmaceuticals, Inc.: Other significant players in the market[1].
• Silvergate Pharmaceuticals: Another company operating in the broader methotrexate drugs market[3].

Financial Performance and Sales

The total U.S. sales of methotrexate sodium 2.5 mg tablets were approximately $63 million for the 12 months ended May 2024, according to IQVIA data[2].

Market Segmentation

The methotrexate sodium market can be segmented by type, application, and region:

• By Type: Includes oral tablets, injectable solutions, and other forms.
• By Application: Cancer treatment, autoimmune diseases (such as rheumatoid arthritis and lupus), and severe psoriasis.
• By Region: North America, Europe, Asia-Pacific, and other regions[1][5].

Challenges and Opportunities

Despite the growth prospects, the market faces several challenges:

• Side Effects and Toxicity: Methotrexate can have severe side effects, which may limit its adoption in some cases.
• Generic Competition: The entry of generic versions, such as those launched by Elite Pharmaceuticals, can increase competition and potentially reduce prices[2].

However, opportunities abound:

• Innovative Formulations: The development of new formulations, such as prefilled syringes and subcutaneous injections, can enhance patient compliance and ease of use[4].
• Expanding Healthcare Access: Increasing healthcare access and reimbursement policies in various regions can drive market growth[4].

Technological and Regulatory Trends

The market is influenced by technological advancements and regulatory changes:

• New Product Launches: Innovations like Cumberland Pharmaceuticals Inc.'s RediTrex injection are enhancing the treatment landscape[4].
• Regulatory Approvals: Approvals from regulatory bodies for new products and formulations are crucial for market expansion[4].

Consumer Behavior and Healthcare Trends

Consumer behavior and broader healthcare trends also play a significant role:

• Patient Awareness: Increasing awareness about the benefits and risks of methotrexate among patients is influencing market dynamics.
• Healthcare Expenditures: Higher healthcare expenditures in regions like North America are driving the adoption of methotrexate sodium[4].

Key Takeaways

• The global methotrexate sodium market is projected to grow to $141.7 million by 2030.
• The broader methotrexate drugs market is expected to reach $0.66 billion by 2032 and $846.99 million by 2037.
• Key drivers include increasing applications in cancer treatment, autoimmune diseases, and severe psoriasis.
• North America and the Asia-Pacific region are expected to be significant markets.
• The competitive landscape includes several key players, with generic competition increasing.

FAQs

Q: What is the forecasted market size of methotrexate sodium by 2030? A: The global market for methotrexate sodium is forecasted to reach $141.7 million by 2030[1].

Q: What is the CAGR of the methotrexate drugs market from 2024 to 2032? A: The methotrexate drugs market is expected to exhibit a CAGR of 2.7% from 2024 to 2032[3].

Q: Which region is expected to dominate the global methotrexate drugs market? A: North America is projected to hold a significant market share of the global methotrexate drugs market[4].

Q: What are the primary applications of methotrexate sodium? A: Methotrexate sodium is used primarily in the treatment of cancer, autoimmune diseases such as rheumatoid arthritis, and severe psoriasis[2].

Q: Which companies are key players in the methotrexate sodium market? A: Key players include Elite Pharmaceuticals, Qualitest (DAVA Pharmaceuticals), Roxane Laboratories Inc., Mylan Pharmaceuticals Inc., and Teva USA (Barr Laboratories)[1][2].

Sources

1. Valuates Reports: Methotrexate Sodium - Global Market Share and Ranking, Overall Market Size.
2. Stock Titan: Elite Pharmaceuticals Announces Commercial Launch of Generic Methotrexate Sodium.
3. Business Research Insights: Methotrexate Drugs Market 2024 To 2032 | Research Report.
4. Research Nester: Methotrexate Drugs Market Size & Share, Forecast Report 2037.
5. Cognitive Market Research: Methotrexate Sodium Market Report 2024 (Global Edition).