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Last Updated: December 25, 2024

METHOTREXATE SODIUM PRESERVATIVE FREE Drug Patent Profile


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When do Methotrexate Sodium Preservative Free patents expire, and when can generic versions of Methotrexate Sodium Preservative Free launch?

Methotrexate Sodium Preservative Free is a drug marketed by Accord Hlthcare, Eugia Pharma Speclts, Hikma, Hospira, Pharmachemie Bv, Rising, Sagent Pharms Inc, and Sandoz. and is included in thirteen NDAs.

The generic ingredient in METHOTREXATE SODIUM PRESERVATIVE FREE 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 Methotrexate Sodium Preservative Free

A generic version of METHOTREXATE SODIUM PRESERVATIVE FREE was approved as methotrexate sodium by HIKMA on September 16th, 1986.

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Cooperative Study Group A for HematologyPhase 3

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Pharmacology for METHOTREXATE SODIUM PRESERVATIVE FREE

US Patents and Regulatory Information for METHOTREXATE SODIUM PRESERVATIVE FREE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 040716-001 Apr 30, 2007 AP RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sagent Pharms Inc METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 203407-003 Aug 9, 2018 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Eugia Pharma Speclts METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 201529-004 Mar 29, 2012 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Eugia Pharma Speclts METHOTREXATE SODIUM PRESERVATIVE FREE methotrexate sodium INJECTABLE;INJECTION 201529-001 Mar 29, 2012 DISCN 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

METHOTREXATE SODIUM PRESERVATIVE FREE Market Analysis and Financial Projection Experimental

Methotrexate Sodium Preservative Free: Market Dynamics and Financial Trajectory

Introduction

Methotrexate Sodium, particularly in its preservative-free form, is a crucial medication used in the treatment of various conditions, including rheumatoid arthritis, psoriasis, and certain types of cancer. This article delves into the market dynamics and financial trajectory of Methotrexate Sodium Preservative Free, highlighting key trends, drivers, and forecasts.

Market Size and Growth

The global methotrexate drugs market, which includes Methotrexate Sodium Preservative Free, has been experiencing steady growth. As of 2022, the global methotrexate drugs market was valued at approximately $590.2 million and is expected to grow at a Compound Annual Growth Rate (CAGR) of 2.6% until 2030[3].

For the specific segment of Methotrexate Sodium, the market is forecasted to reach $141.7 million by 2030, growing from $95 million in 2023 at a CAGR of 5.8% during the period 2024-2030[1].

Key Drivers

Several factors are driving the growth of the Methotrexate Sodium market:

Increasing Prevalence of Autoimmune Diseases

The rising prevalence of autoimmune diseases such as rheumatoid arthritis, juvenile rheumatoid arthritis, and lupus is a significant driver. Methotrexate is often the first-line treatment for these conditions, with about 60% of patients with rheumatoid arthritis currently using it[4].

Regulatory Approvals

The increasing number of drug approvals by regulatory bodies is also boosting market growth. For instance, the launch of new products like RediTrex, a prefilled syringe for subcutaneous administration of methotrexate, has enhanced the market[4].

Technological Innovations

Advancements in drug delivery systems, such as the development of prefilled syringes, are making methotrexate administration more convenient and precise, thereby increasing its adoption[4].

Market Segmentation

The Methotrexate Sodium market can be segmented in several ways:

By Type

The market includes Methotrexate Sodium Tablet and Methotrexate Sodium Solution. The solution form, particularly the preservative-free version, is gaining traction due to its ease of administration and reduced risk of adverse reactions[1].

By Application

Methotrexate Sodium is used in various applications, including oral and injection forms. The injection form, which includes intramuscular, intravenous, subcutaneous, and intrathecal injections, is widely used for treating severe conditions[1][2].

By Region

North America is expected to hold a significant market share, driven by high healthcare expenditures, advanced technologies, and favorable reimbursement policies. The Asia-Pacific region is also expected to see notable growth due to increasing awareness and demand for medical treatments[4].

Competitive Landscape

The Methotrexate Sodium market is competitive, with several key players:

  • Qualitest (DAVA Pharmaceuticals)
  • Roxane Laboratories Inc.
  • Mylan Pharmaceuticals Inc.
  • Teva USA (Barr Laboratories)
  • STADA Pharmaceuticals, Inc.
  • HOSPIRA[1].

These companies are focusing on innovation, product differentiation, and strategic partnerships to maintain their market positions.

Financial Projections

The financial trajectory of the Methotrexate Sodium market is positive, with steady growth anticipated over the next decade. Here are some key financial projections:

  • Global Methotrexate Drugs Market: Expected to reach $846.99 million by 2037, growing at a CAGR of 2.9% from 2025 to 2037[4].
  • Methotrexate Sodium Market: Forecasted to reach $141.7 million by 2030, growing at a CAGR of 5.8% from 2024 to 2030[1].

Challenges and Risks

Despite the growth prospects, the Methotrexate Sodium market faces several challenges:

Side Effects and Safety Concerns

Methotrexate can cause serious side effects, including fertility problems, secondary malignancies, and hepatotoxicity. These risks necessitate careful patient monitoring and adherence to treatment guidelines[2][5].

Regulatory Scrutiny

The market is subject to stringent regulatory oversight, and any changes in regulatory policies can impact market dynamics.

Hospital and Clinical Segment

The hospital segment is expected to garner a significant share of the market due to the increasing number of patients seeking treatment for target diseases. Methotrexate is a common chemotherapy agent, and the rising number of cancer patients undergoing hospitalization for chemotherapy is driving this segment's growth[4].

Regional Insights

North America

North America is projected to hold a significant market share, driven by high adoption of innovative technologies, higher healthcare expenditures, and favorable reimbursement policies. The region is also seeing increased research and development activities related to methotrexate[4].

Asia-Pacific

The Asia-Pacific region is expected to experience notable growth due to increasing awareness of medical treatments and a surging number of female populations requiring medical abortions[4].

Conclusion

The Methotrexate Sodium Preservative Free market is poised for steady growth driven by increasing demand for treatments of autoimmune diseases, technological innovations, and favorable regulatory environments. However, the market must navigate challenges related to side effects and regulatory scrutiny.

Key Takeaways

  • The global methotrexate drugs market is expected to grow at a CAGR of 2.6% until 2030.
  • The Methotrexate Sodium market is forecasted to reach $141.7 million by 2030.
  • Key drivers include the increasing prevalence of autoimmune diseases and technological innovations.
  • North America and the Asia-Pacific region are expected to be significant markets.
  • The hospital segment is anticipated to grow due to the increasing number of patients undergoing chemotherapy.

FAQs

Q: What is the forecasted market size of Methotrexate Sodium by 2030?

A: The Methotrexate Sodium market is forecasted to reach $141.7 million by 2030[1].

Q: What are the main applications of Methotrexate Sodium?

A: Methotrexate Sodium is used in oral and injection forms, including intramuscular, intravenous, subcutaneous, and intrathecal injections[1][2].

Q: Which regions are expected to drive the growth of the Methotrexate Sodium market?

A: North America and the Asia-Pacific region are expected to be significant drivers of market growth[4].

Q: What are the major side effects associated with Methotrexate Sodium?

A: Methotrexate Sodium can cause serious side effects, including fertility problems, secondary malignancies, and hepatotoxicity[2][5].

Q: Who are the key players in the Methotrexate Sodium market?

A: Key players include Qualitest (DAVA Pharmaceuticals), Roxane Laboratories Inc., Mylan Pharmaceuticals Inc., Teva USA (Barr Laboratories), STADA Pharmaceuticals, Inc, and HOSPIRA[1].

Sources

  1. Valuates Reports: Methotrexate Sodium - Global Market Share and Ranking, Overall ...
  2. Pfizer Medical Information: Methotrexate Vial Patient information
  3. Coherent Market Insights: Methotrexate Drugs Market Size, Trends and Forecast to 2030
  4. Research Nester: Methotrexate Drugs Market Size & Share, Forecast Report 2037
  5. Pfizer: METHOTREXATE - CORE DATA SHEET

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