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Last Updated: December 22, 2024

TREXALL Drug Patent Profile


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Which patents cover Trexall, and what generic alternatives are available?

Trexall is a drug marketed by Barr and is included in one NDA.

The generic ingredient in TREXALL is methotrexate sodium. There are twenty drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Trexall

A generic version of TREXALL was approved as methotrexate sodium by HIKMA on September 16th, 1986.

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Recent Clinical Trials for TREXALL

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SponsorPhase
Ohio State UniversityPhase 3
OncoImmune, Inc.Phase 3
Indiana University School of MedicinePhase 3

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Pharmacology for TREXALL

US Patents and Regulatory Information for TREXALL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr TREXALL methotrexate sodium TABLET;ORAL 040385-001 Mar 21, 2001 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Barr TREXALL methotrexate sodium TABLET;ORAL 040385-004 Mar 21, 2001 RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Barr TREXALL methotrexate sodium TABLET;ORAL 040385-002 Mar 21, 2001 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Barr TREXALL methotrexate sodium TABLET;ORAL 040385-003 Mar 21, 2001 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

TREXALL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Methotrexate Drugs (TREXALL)

Introduction

Methotrexate, often marketed under the brand name TREXALL, is a widely used medication for treating various autoimmune diseases and cancers. This article delves into the market dynamics and financial trajectory of methotrexate drugs, highlighting key trends, challenges, and future projections.

Market Size and Growth

The methotrexate drug market is anticipated to experience significant growth over the coming years. As of 2024, the market size is valued at approximately USD 621.3 million and is projected to reach USD 1,058 million by 2034, growing at a Compound Annual Growth Rate (CAGR) of 5.5%[1].

Key Drivers of Market Growth

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

Increasing Prevalence of Autoimmune Diseases

The rising prevalence of autoimmune diseases such as rheumatoid arthritis, psoriasis, and lupus is a major driver. Methotrexate is often the first-line treatment for these conditions, with about 60% of people with rheumatoid arthritis currently taking the drug[4].

Growing Demand for Cancer Treatment

Methotrexate is also widely used in oncology to treat various types of cancers. The increasing incidence rates of cancers, such as prostate, lung, and colorectal cancers, are contributing to the demand for methotrexate[4].

Improvements in Medication Delivery Systems

Advancements in medication delivery systems and formulations are enhancing patient outcomes and adherence. This includes the development of prefilled syringes like RediTrex, which are designed for ease of use and precise dosing[4].

Aging Population and Healthcare Costs

The aging population, which is more prone to cancer and autoimmune diseases, and increasing healthcare costs in developing nations are also boosting the market[3].

Regional Market Dynamics

United States

The U.S. market is expected to register a CAGR of 5.7% from 2024 to 2034. Rising healthcare expenditure, the shift toward value-based care, and increasing interest in integrative medicines are key factors driving growth in this region[1].

Europe

Countries like the United Kingdom are also expected to see significant growth, with a forecasted CAGR of 5.7% during the same period[1].

Asia-Pacific

The market in China is projected to grow at a CAGR of 5.9%, while Japan is expected to see a higher CAGR of 7.0%. These regions are driven by high adoption rates of innovative technologies and increasing healthcare expenditures[1].

Challenges and Restraints

Regulatory Compliance

Stringent regulatory compliance processes are a significant challenge. Methotrexate, being a high-risk drug, faces lengthy and complex regulatory approval processes, which can lead to cost fluctuations and delays[1].

Safety Concerns

The use of methotrexate injections is associated with several risks and negative side effects, including severe complications and life-threatening reactions. These safety concerns can hinder patient acceptance and impact market growth[1].

Pricing and Reimbursement Policies

The availability and cost of methotrexate injections are heavily influenced by pricing and reimbursement policies, which vary by country. These policies can make it difficult for manufacturers to enter the market and gain traction[1].

Financial Trajectory

Revenue Projections

The methotrexate drug market is expected to see substantial revenue growth, from USD 621.3 million in 2024 to USD 1,058 million by 2034. This growth is driven by increasing demand and advancements in treatment options[1].

Research and Development Investments

Companies in the market are investing heavily in research and development to improve methotrexate products. For instance, Medexus Pharmaceuticals has been investing in R&D to prepare for the launch of new products, despite facing challenges like increased R&D costs and regulatory hurdles[2].

Competitive Landscape

The market is becoming increasingly competitive with the entry of new players and the launch of new products. Companies are focusing on innovating new drugs to reduce challenges faced by patients and to provide better outcomes[1].

End-User Segments

Hospitals

The hospital segment is expected to garner a significant share of the market by 2037, driven by the increasing number of patients seeking treatment for target diseases. Methotrexate is commonly used in hospitals for chemotherapy[4].

Specialty Clinics

Specialty clinics are also expected to grow at a significant rate, driven by the high adoption of innovative technologies and the immediate availability of methotrexate pharmacotherapy[4].

Recent Developments

New Product Launches

The launch of new products like RediTrex, a prefilled syringe designed for ease of use and precise dosing, is a recent development that is expected to enhance patient compliance and outcomes[4].

Regulatory Approvals

Companies are working to navigate the complex regulatory landscape to secure approvals for new and improved methotrexate products. For example, U.S. specialty pharmaceutical companies are launching new methotrexate products after gaining regulatory approvals[4].

Key Takeaways

  • The methotrexate drug market is projected to grow significantly, driven by increasing demand for autoimmune and cancer treatments.
  • Regulatory compliance and safety concerns are major challenges.
  • Regional markets, especially in the U.S., China, and Japan, are expected to see substantial growth.
  • Investments in R&D and the launch of new products are key strategies for market players.
  • Hospitals and specialty clinics are significant end-user segments.

FAQs

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

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

Q: What are the primary indications for methotrexate?

A: Methotrexate is primarily used to treat autoimmune diseases such as rheumatoid arthritis, psoriasis, and lupus, as well as various types of cancers[4].

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

A: The major challenges include stringent regulatory compliance processes, safety concerns, and pricing and reimbursement policy issues[1].

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

A: The United States, China, and Japan are expected to see significant growth, driven by high adoption rates of innovative technologies and increasing healthcare expenditures[1].

Q: How are companies addressing the challenges in the methotrexate drug market?

A: Companies are investing in research and development to improve methotrexate products and navigating complex regulatory landscapes to secure approvals for new products[2][4].

Sources

  1. Future Market Insights: Methotrexate Drug Market Size, Share, Trends & Forecast by 2034.
  2. Medexus Pharmaceuticals: Medexus Pharmaceuticals Reports Financial and Operational Results for the Three- and Six-Month Periods Ending September 30, 2021.
  3. Market Research Intellect: Methotrexate Drugs Market Size, Share & Growth by 2031.
  4. Research Nester: Methotrexate Drugs Market Size & Share, Forecast Report 2037.

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