Is there a generic for Fomepizole?

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Fomepizole, referencing the brand ANTIZOL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Fomepizole?

ANTIZOL (NDA 020696, PAR PHARM INC) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Fomepizole?

The Orange Book lists 1 patent against Fomepizole products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Fomepizole are approved?

Fomepizole is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Fomepizole

Fomepizole: 1 brand, 5 generics; first approved Dec 04, 1997; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 5 ANDA applications approved.

Earliest patent expiry Jun 30, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jun 30, 2027

in 8 mo

Brand (NDA) products

Originator applications

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ANTIZOLRLD
PAR PHARM INCNDA 0206961997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5GM/1.5ML (1GM/ML) INJECTABLE INJECTION Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5GM/1.5ML (1GM/ML)	INJECTABLE	INJECTION	Discontinued	-

Generic (ANDA) products (5)

Abbreviated applications

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FOMEPIZOLE
GLANDANDA 2167912023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5GM/1.5ML (1GM/ML) INJECTABLE INJECTION Rx AP
FOMEPIZOLE
MYLAN INSTITUTIONALANDA 0790332009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5GM/1.5ML (1GM/ML) INJECTABLE INJECTION Discontinued -
FOMEPIZOLE
NAVINTA LLCANDA 0785372008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5GM/1.5ML (1GM/ML) INJECTABLE INJECTION Rx AP
FOMEPIZOLERS
MYLAN INSTITUTIONALANDA 0786392008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5GM/1.5ML (1GM/ML) INJECTABLE INJECTION Rx AP
FOMEPIZOLE
AM REGENTANDA 0783682007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5GM/1.5ML (1GM/ML) INJECTABLE INJECTION Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5GM/1.5ML (1GM/ML)	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5GM/1.5ML (1GM/ML)	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5GM/1.5ML (1GM/ML)	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5GM/1.5ML (1GM/ML)	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5GM/1.5ML (1GM/ML)	INJECTABLE	INJECTION	Rx	AP

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7553863	Jun 30, 2027	in 8 mo	SubstanceProduct

Approval history

FDA approval span

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First approval

Dec 04, 1997

29 yr 4 mo ago

Most recent approval

Jul 06, 2023

3 yr 4 mo ago

Approvals span 1997–2023 across 6 FDA applications.

Brand (NDA) 117%

Generic (ANDA) 583%

Fomepizole: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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