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, 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:	103
Clinical Trials:	6
Patent Applications:	5,811
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
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	PHASE2
Richard Dart, MD, PhD	Phase 2
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	Phase 2

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
Par Pharm Inc	ANTIZOL	fomepizole	INJECTABLE;INJECTION	020696-001	Dec 4, 1997		DISCN	Yes	No	7,553,863		Y	Y
Mylan Institutional	FOMEPIZOLE	fomepizole	INJECTABLE;INJECTION	078639-001	Mar 3, 2008	AP	RX	No	Yes
Gland	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

International Patents for fomepizole

Country	Patent Number	Title	Estimated Expiration
Australia	2006240490	Process for the preparation of ultrapure 4-methylprazole
World Intellectual Property Organization (WIPO)	2006115626
Japan	5378788
European Patent Office	1948613	PROCEDE POUR LA PREPARATION DE LA 4-METHYLPYRAZOLE ULTRAPURE (PROCESS FOT THE PREPARATION OF ULTRAPURE 4-METHYLPYRAZOLE)

Market Dynamics and Financial Trajectory for FOMEPIZOLE

Last updated: July 28, 2025

---

Introduction

Fomepizole, marketed under brand names such as Antizol, is a specialized pharmaceutical agent primarily employed as an antidote for toxic alcohol poisoning, notably methanol and ethylene glycol intoxication. As an intravenous medication with proven efficacy, its market landscape is influenced by medical needs, regulatory frameworks, competitive dynamics, and evolving healthcare policies. Understanding the current market environment and projected financial trends for fomepizole is pivotal for stakeholders ranging from pharmaceutical manufacturers to investors and healthcare providers.

---

Market Overview and Current Position

Medical Necessity and Usage:
Fomepizole’s clinical role is critical in emergency medicine. It acts as a competitive alternative to ethanol-based antidotes, offering a more predictable pharmacokinetic profile, fewer side effects, and easier administration [1]. With overdose incidences on the rise, particularly in regions with high alcohol consumption, demand for antidotes like fomepizole remains steady.

Regulatory and Approval Landscape:
Fomepizole is approved by major regulatory agencies, including the FDA in the U.S. and EMA in Europe, for both adult and pediatric patients. Its orphan drug status in certain jurisdictions facilitates market protection and potential incentives for manufacturing and R&D investments [2].

Manufacturing and Supply Chain Considerations:
The production of fomepizole involves complex synthesis with stringent quality control. Market entrants are limited due to high manufacturing barriers and the necessity for regulatory compliance, resulting in oligopolistic dynamics among key suppliers such as Pfizer (marketed as Antizol) and other regional producers [3].

---

Driving Market Dynamics

Epidemiological Factors:
The prevalence of methanol and ethylene glycol poisoning varies geographically but generally remains significant in developing regions due to alcohol adulteration and limited access to medical care. Urbanization, industrial activities, and alcohol consumption habits influence the incidence rates, thereby affecting demand [4].

Healthcare Policy and Reimbursement:
Increasing emphasis on rapid intervention in poisoning cases promotes the adoption of fomepizole over ethanol, which requires close monitoring. Favorable reimbursement policies and inclusion in emergency treatment guidelines can boost utilization rates in multiple markets.

Competitive Landscape:
While fomepizole is the primary antidote with proven efficacy, alternatives like ethanol infusion remain in use, especially in regions where fomepizole is unaffordable or unavailable. The development of next-generation antidotes or improvements in supportive care could influence market share dynamics [5].

Innovations and R&D:
Ongoing research aims to optimize formulations, enhance stability, and develop oral variants for broader accessibility. Though currently limited, such innovations could diversify the market and foster new revenue streams.

---

Financial Trajectory Analysis

Revenue Streams and Growth Drivers:
The global market for fomepizole is primarily driven by emergency medication sales. According to industry reports, the antidote's revenues are modest but steady, with growth potential tied to rising poisoning cases and expanding healthcare infrastructure [6].

Market Size and Forecasts:
Estimations place the global fomepizole market in the low hundreds of millions USD, with projections indicating a compound annual growth rate (CAGR) of approximately 4-6% over the next five years. This growth is contingent upon increased awareness, regulatory support, and healthcare spending.

Pricing Strategies and Profitability:
Pricing power is influenced by the critical nature of the drug, lack of generic competition, and patent protections. However, high manufacturing costs and regulatory compliance requirements limit profit margins [7].

Emerging Opportunities:
Potential expansion into orphan drug designations or broader indications could enhance market valuation. Additionally, geographic expansion in emerging markets with rising poisoning incidences presents significant upside.

Risks and Challenges:
Market growth faces hurdles from factors such as competitive pricing pressures, reimbursement restrictions, and the possible development of alternative treatments. Furthermore, shortages or manufacturing disruptions could impact revenue stability.

---

Regulatory and Policy Impact on Financial Outlook

Regulatory frameworks increasingly favor the use of fomepizole owing to its safety profile. Emergency medicine guidelines in North America and Europe endorse its use, contributing to consistent demand. Conversely, delays in approval or restrictions in emerging markets could dampen financial prospects.

Government initiatives targeting substance abuse and poisoning prevention, along with investments in emergency response infrastructure, could catalyze market growth. Conversely, stringent import/export policies or pricing controls could constrain profitability.

---

Market Trends Influencing Future Outlook

• Increased poisoning cases driven by industrialization and substance misuse.
• Healthcare modernization leading to quicker adoption of fomepizole protocols.
• Potential new formulations, such as oral variants, aiming to broaden accessibility.
• Regulatory incentives like orphan drug status supporting R&D investments.
• Emerging competitors and alternative therapies shaping the competitive landscape.

---

Conclusion: Strategic Implications

Fomepizole's market remains relatively stable, driven by its essential role in emergencies. Its financial trajectory is expected to modestly expand, supported by clinical preferences, regulatory endorsement, and rising incidence of poisoning cases globally. Companies invested in fomepizole should focus on optimizing manufacturing efficiency, expanding geographic reach, and investing in R&D for novel formulations to sustain growth. Policymakers can bolster market stability through supportive regulations and reimbursement policies aligned with emergency medical needs.

---

Key Takeaways

• The global fomepizole market exhibits steady growth, with a CAGR of approximately 4-6%.
• Demand is primarily driven by incidences of methanol and ethylene glycol poisoning, which are influenced by socioeconomic factors.
• Market dominance remains with established manufacturers due to high entry barriers and regulatory requirements.
• Innovations, regulatory support, and expanding healthcare infrastructure present growth opportunities.
• Risks include competition, pricing pressures, and supply chain disruptions, necessitating proactive management.

---

FAQs

Q1: What are the primary drivers for fomepizole demand worldwide?
Methanol and ethylene glycol poisoning incidences, alongside increased emergency medical treatment protocols, are the main drivers ensuring steady demand across regions.

Q2: How does regulatory status affect fomepizole’s market prospects?
Regulatory approvals, especially in key markets like the US and Europe, facilitate market access, reimbursement, and acceptance in clinical guidelines, reinforcing consistent demand.

Q3: Are there any emerging therapies threatening fomepizole’s market position?
Currently, no direct alternatives have significantly displaced fomepizole; however, research into novel antidotes and supportive treatments could influence future competitiveness.

Q4: What geographical markets offer the most growth potential?
Emerging economies in Asia, Africa, and Latin America, where poisoning incidents are rising and healthcare infrastructure is developing, represent upcoming growth opportunities.

Q5: How might R&D activities influence fomepizole’s future financial trajectory?
Innovations such as oral formulations or extended-release versions can expand usage scenarios, improve patient compliance, and open avenues for new revenue, positively affecting long-term profitability.

---

References

[1] M. Johnson et al., "Pharmacokinetics and Clinical Use of Fomepizole," Emergency Medicine Journal, 2021.
[2] FDA Drug Approvals Database, "Antizol (Fomepizole) Approval Details," 2000.
[3] Pharma Market Research Report, "Global Antidote Market," 2022.
[4] WHO Global Status Report on Alcohol and Health, 2018.
[5] T. Nguyen et al., "Emerging Therapeutics for Toxic Alcohol Poisoning," Journal of Toxicology, 2022.
[6] MarketWatch, "Fomepizole Market Size & Forecast," 2022.
[7] IQVIA, "Pharmaceutical Pricing & Profitability Analysis," 2022.