FDA Orange Book · active-ingredient family
Cidofovir
Cidofovir: 1 brand, 2 generics; first approved Jun 26, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 2 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
2
Listed patents
0
Presentations
3
Brand (NDA) products
Originator applications
- VISTIDERLDGILEAD SCIENCES INCNDA 0206381996
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 375MG BASE/5ML (EQ 75MG BASE/ML) SOLUTION INTRAVENOUS Discontinued —
Generic (ANDA) products (2)
Abbreviated applications
- CIDOFOVIRAVET LIFESCIENCESANDA 2025012012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 375MG BASE/5ML (EQ 75MG BASE/ML) SOLUTION INTRAVENOUS Rx AP - CIDOFOVIRRSMYLAN INSTITUTIONALANDA 2012762012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 375MG BASE/5ML (EQ 75MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
30 yr 7 mo ago
Most recent approval
14 yr 3 mo ago
Approvals span 1996–2012 across 3 FDA applications.
Brand (NDA) 133%
Generic (ANDA) 267%
Cidofovir: 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.
