ANTIZOL Drug Patent Profile

Which patents cover Antizol, and when can generic versions of Antizol launch?

Antizol is a drug marketed by Par Pharm Inc and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has nine patent family members in eight countries.

The generic ingredient in ANTIZOL is fomepizole. There are five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fomepizole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Antizol

A generic version of ANTIZOL was approved as fomepizole by AM REGENT on December 14^th, 2007.

Summary for ANTIZOL

International Patents:	9
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	163
Clinical Trials:	2
Patent Applications:	1,735
What excipients (inactive ingredients) are in ANTIZOL?	ANTIZOL excipients list
DailyMed Link:	ANTIZOL at DailyMed

Recent Clinical Trials for ANTIZOL

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

Sponsor	Phase
Ted Daley, President	Phase 2
Raptor Pharmaceuticals Inc.	Phase 2
Horizon Pharma USA, Inc.	Phase 2

See all ANTIZOL clinical trials

Paragraph IV (Patent) Challenges for ANTIZOL

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 ANTIZOL

ANTIZOL is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Par Pharm Inc	ANTIZOL	fomepizole	INJECTABLE;INJECTION	020696-001	Dec 4, 1997		DISCN	Yes	No	7,553,863		Y	Y

International Patents for ANTIZOL

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

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

ANTIZOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ANTIZOL (Fomepizole)

Market Overview

The global market for ANTIZOL (fomepizole), also known as 4-methylpyrazole, is characterized by steady growth driven by specific medical needs and regulatory approvals. Here are the key dynamics shaping this market:

Growing Incidence of Methanol and Ethylene Glycol Poisoning

The increasing incidence of methanol and ethylene glycol poisoning is a primary driver of the ANTIZOL market. These types of poisonings are life-threatening and require immediate medical intervention, making ANTIZOL a critical antidote in emergency and critical care settings[1].

Product Formulation and Administration

ANTIZOL is available in an injectable formulation, which is crucial for prompt parenteral administration in emergency situations. This formulation caters to the specific needs of healthcare providers and patients, enhancing its market appeal[1].

Competitive Landscape

The market for ANTIZOL is dominated by a limited number of key players, primarily due to the specialized nature of the medication. Jazz Pharmaceuticals is one of the major players, marketing ANTIZOL primarily to hospitals and emergency rooms[3].

Regulatory Approvals and Healthcare Policies

Regulatory approvals and healthcare policies play a significant role in shaping the market dynamics. ANTIZOL is the only FDA-approved antidote for suspected or confirmed ethylene glycol or methanol poisonings, which has contributed to its market position[3].

Market Growth and Projections

Current Market Size and Growth Rate

As of 2023, the global fomepizole market was valued at approximately USD 37 million. It 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 Factors Contributing to Growth

Several factors are driving the growth of the ANTIZOL market:

• Increasing Incidence of Poisoning: The rising cases of methanol and ethylene glycol poisoning necessitate the use of effective antidotes like ANTIZOL.
• Advancements in Healthcare Systems: Improvements in healthcare infrastructure, particularly in regions like North America and Europe, have enhanced the accessibility and use of specialized antidotes.
• Research and Development: Ongoing efforts to explore new therapeutic applications and improve formulations of fomepizole are further boosting market growth[1].

Regional Market Dynamics

Global Footprint

The ANTIZOL market has a global footprint with varying market sizes and growth rates across different regions:

• North America: This region, particularly the United States, is a leading market due to its well-established healthcare infrastructure and reimbursement policies for specialized antidotes.
• Europe: Countries like Germany, the United Kingdom, and France are significant contributors to the European market.
• Asia-Pacific: This region is expected to experience the fastest growth, driven by increasing awareness about the management of methanol and ethylene glycol poisoning and the expansion of healthcare systems in countries like China, India, and Japan[1].

Financial Performance and Revenue

Historical Revenue

Jazz Pharmaceuticals, a key player in the market, reported net product sales of ANTIZOL as $12.5 million in 2006 and $2.6 million in the first quarter of 2007. These figures indicate a steady revenue stream from the product[3].

Distribution and Marketing

ANTIZOL is distributed to wholesalers in the United States and marketed by distributors in Canada and Israel. The product's financial performance is also influenced by its distribution channels and marketing strategies[3].

Market Restraints

Despite the growth potential, the ANTIZOL market faces several challenges:

• Limited Patient Population: Methanol and ethylene glycol poisoning are relatively rare, which limits the target market and overall demand for ANTIZOL.
• High Cost: The specialized nature of ANTIZOL makes it expensive, which can be a barrier to its widespread adoption, especially in regions with limited healthcare resources.
• Alternative Treatments: The availability of alternative treatments, such as ethanol or hemodialysis, can impact the demand for ANTIZOL[1].

Future Outlook

Technological Advancements and New Therapeutic Applications

The future growth of the ANTIZOL market will be influenced by several factors:

• Improved Formulations: Research aimed at developing more affordable and safer formulations of fomepizole.
• Technological Advancements: Integration of technological advancements in drug delivery systems.
• Personalized Medicine: Increasing emphasis on personalized and patient-centric approaches to medical treatment.
• Digital Health Solutions: The growing adoption of digital health solutions may also shape the future of the ANTIZOL market[1].

Key Takeaways

• The ANTIZOL market is driven by the increasing incidence of methanol and ethylene glycol poisoning and advancements in healthcare systems.
• The market is projected to grow at a CAGR of 5.2% from 2024 to 2033.
• Regulatory approvals and the specialized nature of the medication contribute to its market position.
• Regional variations in market size and growth rates are significant, with North America and Europe being leading markets.
• Challenges include a limited patient population, high cost, and the availability of alternative treatments.

FAQs

What is ANTIZOL (fomepizole) used for?

ANTIZOL (fomepizole) is used as an antidote for suspected or confirmed ethylene glycol or methanol poisoning.

What is the mechanism of action of ANTIZOL?

ANTIZOL works as a competitive inhibitor of alcohol dehydrogenase, preventing the metabolism of ethylene glycol and methanol into their toxic metabolites[2].

What are the key factors driving the growth of the ANTIZOL market?

Key factors include the increasing incidence of methanol and ethylene glycol poisoning, advancements in healthcare systems, and ongoing research and development efforts[1].

Which regions are expected to see the fastest growth in the ANTIZOL market?

The Asia-Pacific region is expected to experience the fastest growth, driven by increasing awareness and the expansion of healthcare systems in countries like China, India, and Japan[1].

What are the main challenges facing the ANTIZOL market?

Challenges include a limited patient population, the high cost of the medication, and the availability of alternative treatments such as ethanol or hemodialysis[1].

Sources

1. Data Horizzon Research: Fomepizole (4-Methylpyrazole) Market Size, Share, Growth, Trends, Statistics Analysis Report, By Region, and Segment Forecasts 2024 – 2033.
2. FDA: ANTIZOL® (fomepizole) Injection.
3. Jazz Pharmaceuticals: Investor Presentation.