XATMEP Drug Patent Profile

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

Xatmep is a drug marketed by Azurity and is included in one NDA. There are six patents protecting this drug.

This drug has three patent family members in three countries.

The generic ingredient in XATMEP 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 Xatmep

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

Summary for XATMEP

International Patents:	3
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	2
Patent Applications:	4,416
Drug Prices:	Drug price information for XATMEP
What excipients (inactive ingredients) are in XATMEP?	XATMEP excipients list
DailyMed Link:	XATMEP at DailyMed

See drug prices for XATMEP

Recent Clinical Trials for XATMEP

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2

See all XATMEP clinical trials

Pharmacology for XATMEP

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

US Patents and Regulatory Information for XATMEP

XATMEP is protected by eight US patents and two FDA Regulatory Exclusivities.

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	10,231,927
Azurity	XATMEP	methotrexate sodium	SOLUTION;ORAL	208400-001	Apr 25, 2017		RX	Yes	Yes	9,855,215		Y
Azurity	XATMEP	methotrexate sodium	SOLUTION;ORAL	208400-001	Apr 25, 2017		RX	Yes	Yes	9,259,427		Y

International Patents for XATMEP

See the table below for patents covering XATMEP around the world.

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

XATMEP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Xatmep

Introduction to Xatmep

Xatmep, a ready-to-use methotrexate oral solution, is a significant player in the pharmaceutical market, particularly for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and active polyarticular juvenile idiopathic arthritis (PJIA). Here, we delve into the market dynamics and financial trajectory of Xatmep.

Market Size and Growth

The global Xatmep market was valued at USD 131 million in 2022 and is projected to grow to USD 180.67 million by 2030, with a Compound Annual Growth Rate (CAGR) of 4.10% during the forecast period of 2023-2030[1][3].

Segmentation of the Xatmep Market

The market is segmented based on several factors:

• Dose Types: The market is bifurcated into 2mg/ml and 2.5mg/ml, with the 2.5mg/ml segment holding a significant market share due to its approval for cancer and autoimmune diseases[3].
• Applications: Key applications include acute lymphoblastic leukemia (ALL), active polyarticular juvenile idiopathic arthritis (PJIA), and others. The ALL segment accounts for a substantial share of the market[3].
• Distribution Channel: Hospital pharmacies, retail pharmacies, and online pharmacies are the primary distribution channels, with hospital pharmacies expected to grow rapidly[3].
• End-Users: Hospitals, specialty clinics, and homecare are the main end-users, with hospitals dominating the market[1][3].

Drivers of Market Growth

Several factors drive the growth of the Xatmep market:

• Increasing Prevalence of Cancer: The rising incidence of cancer, including urothelial cancer and cell carcinoma, significantly boosts the demand for Xatmep. According to the World Health Organization (WHO), cancer accounted for approximately 10 million deaths in 2020[1].
• Growing Healthcare Expenditure: Increasing healthcare spending and improvements in healthcare infrastructure, particularly in North America, contribute to the market's growth[1].
• Pediatric Population and Autoimmune Diseases: The growing pediatric population with immune system diseases and the increasing incidence of arthritis disorders drive the market forward[1][3].
• Research and Development: An increase in research and development activities, especially in emerging markets, provides beneficial opportunities for the Xatmep market[1][3].

Restraints and Challenges

Despite the growth drivers, the Xatmep market faces several challenges:

• High Cost of Drug Development: The high costs associated with drug development and distribution are significant restraints. Additionally, the lack of skilled professionals and inadequate healthcare infrastructure in developing economies hinder market growth[1][3].
• Side Effects and FDA Guidelines: The side effects of Xatmep, such as ulcerative stomatitis, leukopenia, and nausea, along with strict FDA guidelines for new drug approvals, act as restraints to the market's growth[1][3].

Regional Analysis

The global Xatmep market is analyzed across various regions:

• North America: This region is expected to dominate the market due to the high prevalence of acute leukemia, significant healthcare expenditure, and the presence of skilled professionals[1][3].
• Europe: Europe holds a substantial market share, driven by a growing population, high healthcare spending, and advanced cancer treatments in the region[3].
• Asia Pacific: The market in this region is expected to grow rapidly due to a growing population, rising chronic disorders, and increasing government initiatives to improve healthcare infrastructure[3].

Patient Support and Financial Assistance

To make Xatmep more accessible, patient support programs are in place:

• Azurity Solutions Patient Assistance Program: This program helps eligible patients by covering out-of-pocket expenses, making the medication available for as little as $5 for commercially insured patients[2].

Key Players

The market is influenced by key players such as:

• Azurity Pharmaceuticals, Inc.: The company behind the FDA-approved Xatmep oral solution, which is the first and only FDA-approved methotrexate oral solution for pediatric patients[3][4].

Technological Innovations and Market Opportunities

Technological innovations in generic drug treatment and rising healthcare spending create lucrative opportunities for the Xatmep market. The ready-to-use formulation of Xatmep, which eliminates the need for needles, tablet crushing, or compounding, enhances its market appeal and convenience[1][3].

Financial Trajectory

The financial trajectory of Xatmep is positive, with a projected growth from USD 131 million in 2022 to USD 180.67 million by 2030. This growth is driven by increasing demand, advancements in healthcare infrastructure, and ongoing research and development activities.

"The rising prevalence of cancer, such as urothelial cancer, cell carcinoma, and others, is estimated to enhance the xatmep market's growth rate. Cancer is the greatest cause of mortality worldwide, according to the World Health Organization (WHO), accounting for approximately 10 million deaths in 2020, or nearly one in every six deaths."[1]

Key Takeaways

• The global Xatmep market is expected to grow at a CAGR of 4.10% from 2023 to 2030.
• The market is driven by the increasing prevalence of cancer, growing healthcare expenditure, and the need for convenient and accurate drug formulations.
• North America is expected to dominate the market due to high healthcare spending and the presence of skilled professionals.
• Patient support programs are crucial in making Xatmep accessible to a wider patient base.
• Technological innovations and rising healthcare spending present significant opportunities for market growth.

Frequently Asked Questions (FAQs)

What is Xatmep used for?

Xatmep is used for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and active polyarticular juvenile idiopathic arthritis (PJIA)[3][4].

What are the key drivers of the Xatmep market?

The key drivers include the increasing prevalence of cancer, growing healthcare expenditure, and the need for convenient and accurate drug formulations[1][3].

Which region is expected to dominate the Xatmep market?

North America is expected to dominate the Xatmep market due to high healthcare spending and the presence of skilled professionals[1][3].

What are the main challenges facing the Xatmep market?

The main challenges include the high cost of drug development, side effects of the medication, and strict FDA guidelines for new drug approvals[1][3].

How does the Azurity Solutions Patient Assistance Program help patients?

The program helps eligible patients by covering out-of-pocket expenses, making Xatmep available for as little as $5 for commercially insured patients[2].

Sources:

1. Data Bridge Market Research - Global Xatmep Market – Industry Trends and Forecast to 2030
2. Xatmep - Coverage & Patient Support - XATMEP (methotrexate) oral solution
3. Growth Market Reports - Xatmep Market Size, Share, Growth, Industry & Revenue [2031]
4. FDA - 208400Orig1Orig2s000 CLINICAL REVIEW(S)