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
Brands (NDA)
1
Generics (ANDA)
5
Listed patents
1
Next patent expiry
Jun 30, 2027
in 9 mo
Brand (NDA) products
Originator applications
- ANTIZOLRLDPAR PHARM INCNDA 0206961997
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
- FOMEPIZOLEGLANDANDA 2167912023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5GM/1.5ML (1GM/ML) INJECTABLE INJECTION Rx AP - FOMEPIZOLEMYLAN INSTITUTIONALANDA 0790332009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5GM/1.5ML (1GM/ML) INJECTABLE INJECTION Discontinued — - FOMEPIZOLENAVINTA LLCANDA 0785372008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5GM/1.5ML (1GM/ML) INJECTABLE INJECTION Rx AP - FOMEPIZOLERSMYLAN INSTITUTIONALANDA 0786392008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5GM/1.5ML (1GM/ML) INJECTABLE INJECTION Rx AP - FOMEPIZOLEAM REGENTANDA 0783682007
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
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7553863 | in 9 mo | SubstanceProduct |
Approval history
FDA approval span
First approval
29 yr 3 mo ago
Most recent approval
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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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