Fomepizole - Generic Drug Details

What are the generic drug sources for fomepizole and what is the scope of freedom to operate?

Fomepizole is the generic ingredient in two branded drugs marketed by Par Pharm Inc, Am Regent, Gland Pharma Ltd, Mylan Institutional, and Navinta Llc, and is included in six NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Fomepizole has nine patent family members in eight countries.

There are five drug master file entries for fomepizole. Six suppliers are listed for this compound.

Summary for fomepizole

International Patents:	9
US Patents:	1
Tradenames:	2
Applicants:	5
NDAs:	6
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	163
Clinical Trials:	5
Patent Applications:	3,087
Drug Prices:	Drug price trends for fomepizole
What excipients (inactive ingredients) are in fomepizole?	fomepizole excipients list
DailyMed Link:	fomepizole at DailyMed

See drug prices for fomepizole

Recent Clinical Trials for fomepizole

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

Sponsor	Phase
Richard Dart, MD, PhD	Phase 2
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	Phase 2
University of Arizona	Early Phase 1

See all fomepizole clinical trials

Pharmacology for fomepizole

Drug Class

Antidote

Anatomical Therapeutic Chemical (ATC) Classes for fomepizole

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for FOMEPIZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ANTIZOL	Injection	fomepizole	1.5 g/1.5 mL	020696	1	2021-11-01
ANTIZOL	Injection	fomepizole	1.5 g/1.5 mL	020696	1	2014-04-14

US Patents and Regulatory Information for fomepizole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Institutional	FOMEPIZOLE	fomepizole	INJECTABLE;INJECTION	079033-001	Apr 7, 2009		DISCN	No	No
Mylan Institutional	FOMEPIZOLE	fomepizole	INJECTABLE;INJECTION	078639-001	Mar 3, 2008	AP	RX	No	Yes
Par Pharm Inc	ANTIZOL	fomepizole	INJECTABLE;INJECTION	020696-001	Dec 4, 1997		DISCN	Yes	No			Y	Y
Gland Pharma Ltd	FOMEPIZOLE	fomepizole	INJECTABLE;INJECTION	216791-001	Jul 6, 2023	AP	RX	No	No
Navinta Llc	FOMEPIZOLE	fomepizole	INJECTABLE;INJECTION	078537-001	Mar 6, 2008	AP	RX	No	No
Am Regent	FOMEPIZOLE	fomepizole	INJECTABLE;INJECTION	078368-001	Dec 14, 2007	AP	RX	No	No

International Patents for fomepizole

Country	Patent Number	Title	Estimated Expiration
China	101163679	Method of preparing ultrapure 4-methylpyrazole
European Patent Office	1948613	PROCEDE POUR LA PREPARATION DE LA 4-METHYLPYRAZOLE ULTRAPURE (PROCESS FOT THE PREPARATION OF ULTRAPURE 4-METHYLPYRAZOLE)
Australia	2006240490	Process for the preparation of ultrapure 4-methylprazole
Japan	5378788
Mexico	2007013118	PROCESO PARA LA PREPARACION DE 4-METILPIRAZOL ULTRAPURO. (PROCESS FOR THE PREPARATION OF ULTRAPURE 4-METHYLPRAZOLE.)
Japan	2008538560

Fomepizole Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fomepizole (4-Methylpyrazole)

Market Overview

The global fomepizole (4-methylpyrazole) market is experiencing steady growth, driven by several key factors. As of 2023, the market was valued at approximately USD 37 million and is projected to reach about USD 61 million by 2033, growing at a Compound Annual Growth Rate (CAGR) of 5.2% during the forecast period from 2024 to 2033[1].

Key Drivers of Market Growth

Increasing Incidence of Methanol and Ethylene Glycol Poisoning

The rising incidence of methanol and ethylene glycol poisoning is a significant driver of the fomepizole market. These types of poisonings are life-threatening and require immediate medical intervention, making fomepizole, as an effective antidote, a crucial component in emergency and critical care settings[1].

Advancements in Healthcare Systems

Improvements in healthcare infrastructure, particularly in regions like North America and Europe, have enhanced the availability and accessibility of fomepizole. This has contributed to the market's growth by ensuring that healthcare providers have the necessary resources to manage acute poisonings effectively[1].

Rising Awareness About Effective Antidote Treatments

Increasing awareness among healthcare professionals and the general public about the importance of prompt and effective treatment for methanol and ethylene glycol poisoning has also driven the demand for fomepizole. This awareness is particularly significant in emerging markets where the incidence of such poisonings is high[1].

Market Segmentation

By Product Type

Fomepizole is primarily available in an injectable formulation, which is critical for its use in emergency settings where rapid administration is necessary. This formulation caters to the specific needs of healthcare providers and patients requiring immediate treatment[1].

By End-User Application

The market is segmented by end-user applications, including emergency departments, intensive care units, and poison control centers. These settings are the primary consumers of fomepizole due to the urgent need for antidotes in managing acute poisonings[1].

By Distribution Channel

The distribution channels for fomepizole include hospitals, pharmacies, and other healthcare facilities. The market dynamics are influenced by the efficiency and reach of these distribution channels, ensuring that the drug is readily available where it is most needed[1].

Competitive Landscape

The fomepizole market is characterized by a limited number of key players due to the specialized nature of the medication. This limited competition from generic manufacturers has allowed existing players to maintain a strong market presence. However, ongoing research and development efforts to explore new therapeutic applications and improve formulations are expected to attract more players to the market[1].

Regional Market Dynamics

North America

North America, particularly the United States, is a leading market for fomepizole. The well-established healthcare infrastructure, availability of reimbursement for specialized antidotes, and the presence of key market players contribute to its dominance in the market[1].

Europe

Europe is another prominent region, with countries like Germany, the United Kingdom, and France playing significant roles. The region's advanced healthcare systems and regulatory frameworks support the market's growth[1].

Asia-Pacific

The Asia-Pacific region is expected to experience the fastest growth, driven by increasing awareness about the importance of prompt management of methanol and ethylene glycol poisoning, expansion of healthcare systems, and the growing burden of these types of poisoning incidents in countries like China, India, and Japan[1].

Latin America and Middle East & Africa

These regions also present opportunities for market growth, although the availability and accessibility of fomepizole may be relatively lower compared to other regions. As awareness and healthcare infrastructure improve, these markets are expected to contribute significantly to the overall growth of the fomepizole market[1].

Technological Advancements and Future Trends

Novel Drug Delivery Systems

The integration of technological advancements, such as the development of novel drug delivery systems, is expected to enhance the convenience, safety, and efficacy of fomepizole-based treatments. These innovations could include patient-centric features that improve the administration and monitoring of the drug[1].

Personalized and Patient-Centric Approaches

The increasing emphasis on personalized and patient-centric approaches to medical treatment, along with the growing adoption of digital health solutions, may also shape the future of the fomepizole market. These approaches could lead to more tailored treatment plans and better patient outcomes[1].

Challenges and Restraints

Limited Patient Population

One of the significant challenges facing the fomepizole market is the limited patient population. Since fomepizole is used for specific types of poisonings, the market size is inherently limited compared to more broadly used medications[1].

High Cost of the Antidote

The high cost of fomepizole is another restraint. This can make the drug less accessible in regions with limited healthcare resources, affecting its overall market growth[1].

Evolving Regulatory Landscape

The evolving regulatory landscape can also pose challenges. Changes in healthcare policies and regulatory approvals can impact the market dynamics and the availability of fomepizole in different regions[1].

Financial Trajectory

The financial trajectory of the fomepizole market is positive, with a projected CAGR of 5.2% from 2024 to 2033. Here are some key financial highlights:

• Market Value: The global fomepizole market was valued at approximately USD 37 million in 2023 and is expected to reach about USD 61 million by 2033[1].
• Revenue Growth: The market is expected to grow steadily, driven by the increasing incidence of methanol and ethylene glycol poisoning and advancements in healthcare systems[1].
• Regional Contributions: North America and Europe are currently the largest contributors to the market, but the Asia-Pacific region is expected to show the fastest growth rate in the coming years[1].

Key Takeaways

• The fomepizole market is driven by the rising incidence of methanol and ethylene glycol poisoning and advancements in healthcare systems.
• The market is characterized by a limited number of key players and is segmented by product type, end-user application, and distribution channel.
• Regional dynamics vary, with North America and Europe being leading markets, and the Asia-Pacific region showing the fastest growth.
• Technological advancements and personalized treatment approaches are expected to shape the future of the market.
• Challenges include a limited patient population, high cost of the antidote, and an evolving regulatory landscape.

FAQs

1. What is the current market size of the fomepizole (4-methylpyrazole) market? The global fomepizole market was valued at approximately USD 37 million in 2023[1].

2. What is the projected growth rate of the fomepizole market from 2024 to 2033? The market is projected to grow at a CAGR of 5.2% from 2024 to 2033[1].

3. Which regions are expected to drive the growth of the fomepizole market? North America and Europe are currently the largest markets, but the Asia-Pacific region is expected to show the fastest growth rate in the coming years[1].

4. What are the main challenges facing the fomepizole market? The main challenges include a limited patient population, the high cost of the antidote, and an evolving regulatory landscape[1].

5. How is technological advancement expected to impact the fomepizole market? Technological advancements, such as novel drug delivery systems and personalized treatment approaches, are expected to enhance the convenience, safety, and efficacy of fomepizole-based treatments[1].

Cited Sources

1. Data Horizon Research: Fomepizole (4-Methylpyrazole) Market Size, Share, Growth, Trends, Statistics Analysis Report[1].
2. Sobi: Pioneer in Rare Diseases[2].
3. Market Research Intellect: Global Dolutegravir Rilpivirine Combination Drug Market[3].
4. QY Research: Fomepizole（4-Methylpyrazole） - Global Market Insights and Sales[4].
5. Market Intellix: Fomepizole API Global and China Top Players Market[5].