FOMEPIZOLE Drug Patent Profile

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

Fomepizole is a drug marketed by Am Regent, Gland, Mylan Institutional, and Navinta Llc. and is included in five NDAs.

The generic ingredient in FOMEPIZOLE 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 Fomepizole

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

Summary for FOMEPIZOLE

US Patents:	0
Applicants:	4
NDAs:	5
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	6
Patent Applications:	3,383
Drug Prices:	Drug price information for FOMEPIZOLE
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
Am Regent	FOMEPIZOLE	fomepizole	INJECTABLE;INJECTION	078368-001	Dec 14, 2007	AP	RX	No	No
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
Mylan Institutional	FOMEPIZOLE	fomepizole	INJECTABLE;INJECTION	079033-001	Apr 7, 2009		DISCN	No	No

Market Dynamics and Financial Trajectory for Fomepizole

Last updated: February 20, 2026

What Is the Current Market Size for Fomepizole?

Fomepizole, marketed as Antizol, is a drug used to treat methanol and ethylene glycol poisoning. The global market for fomepizole was valued at approximately $75 million in 2022. It is expected to grow at a compound annual growth rate (CAGR) of around 8% from 2023 to 2030, reaching roughly $125 million by 2030. Nearly all sales are concentrated within North America, which accounts for over 85% of the revenue due to high incidence rates of poisoning and intense regulatory adoption.

What Factors Drive Market Growth?

1. Incidence of Poisoning Cases: The rise in methanol and ethylene glycol poisoning cases, especially in regions with limited access to rapid antidote options, sustains demand.
2. Regulatory Approvals and Guidelines: The American Academy of Clinical Toxicology and the American Academy of Pediatrics endorse fomepizole as a first-line treatment, fostering market adoption.
3. Unmet Medical Need: Limited alternative therapies exist. Ethanol is an off-label alternative with less favorable safety profiles and logistical challenges.
4. Expanding Use Cases: Emerging evidence supports fomepizole’s potential use in other toxicological emergencies, boosting its clinical utility.

How Does Pricing Influence Market Revenue?

Fomepizole's price per treatment course averages $2,500 to $3,000 in North America, depending on treatment length and dosage. The high cost acts as a barrier in some regions, but reimbursement policies and hospital procurement contracts sustain revenues in developed markets.

Specification	Details
Average Treatment Cost	$2,500 - $3,000
Dose per Treatment	15-20 mg/kg (initial), followed by maintenance doses
Treatment Duration	24-72 hours depending on severity

What Are Barriers and Challenges?

• Limited Global Availability: Distribution is concentrated mainly in U.S. and Europe; emerging markets face access constraints.
• Pricing and Reimbursement: High costs limit usage in lower-income countries; reimbursement policies favor North America.
• Competitive Alternatives: Ethanol remains an off-label therapy, although less preferred.
• Supply Chain Vulnerability: Dependence on specific manufacturing facilities raises risks of shortages.

Who Are the Major Players?

• Drug Manufacturers: Harris Pharmaceutical (India), Hospira (Pfizer), and generic producers supply fomepizole globally.
• Research Organizations: Clinical research efforts aim to find new formulations and alternative antidotes.
• Regulatory Agencies: U.S. FDA approved fomepizole in 1999; European Medicines Agency followed in 2002.

What Does the R&D and Pipeline Look Like?

Fomepizole has minimal pipeline activity. Most innovation revolves around manufacturing improvements and new dosing protocols. No new formulations or indications are currently in advanced clinical trials, limiting potential expansion opportunities.

How Might Market Dynamics Change?

• Emerging Markets: Growth in India, China, and Latin America could expand market size, provided that pricing and distribution obstacles are addressed.
• Regulatory Developments: Potential approvals for broader indications could increase demand.
• R&D Progress: Breakthroughs in alternative antidotes or formulations may influence competitive positioning.

Financial Trajectory Summary

Year	Market Size (USD millions)	Expected Growth Rate	Notes
2022	75	—	Base year
2023	81	8%	Initiation of expansion in emerging markets
2025	100	8% CAGR	Increased access in low-income regions
2030	125	8% CAGR	Full penetration in targeted emerging markets

Key Takeaways

• The fomepizole market is growing steadily driven by clinical demand and regulatory endorsement.
• North America dominates the market, with high drug prices supporting revenue.
• Barriers include limited access in emerging markets and high costs.
• R&D activity is limited to manufacturing efficiency and protocol optimization.
• Future growth depends on regional expansion, innovative formulations, and potential new indications.

FAQs

1. What limits the global adoption of fomepizole? Limited distribution infrastructure, high treatment costs, and regulatory approval differences hinder widespread adoption in low-income regions.

2. Will new formulations affect the market? Currently, no. R&D focuses on manufacturing improvements and protocol optimization. New formulations are not in clinical development.

3. How vulnerable is the market to regulatory changes? Significant; approval for new indications or indications in additional jurisdictions could boost sales. Conversely, delays may constrain growth.

4. Are there alternative therapies? Yes. Ethanol is used off-label but has logistical and safety disadvantages. No new antidotes are close to market approval.

5. How might the COVID-19 pandemic impact demand? The pandemic’s effect is uncertain; it may slightly reduce elective treatments but has limited impact on acute poisoning emergencies.

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References

[1] MarketWatch. (2023). Fomepizole market size and forecast.
[2] U.S. Food and Drug Administration. (1999). Fomepizole approval documentation.
[3] European Medicines Agency. (2002). Fomepizole authorization.