FDA Orange Book · active-ingredient family
Atovaquone
Atovaquone: 2 brands, 9 generics; first approved Nov 25, 1992; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
9
Listed patents
0
Presentations
11
Brand (NDA) products
Originator applications
Generic (ANDA) products (9)
Abbreviated applications
- ATOVAQUONEPAI HOLDINGSANDA 2142722021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG/5ML SUSPENSION ORAL Rx AB - ATOVAQUONEBIONPHARMAANDA 2129182021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG/5ML SUSPENSION ORAL Rx AB - ATOVAQUONEABHAI LLCANDA 2105102019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG/5ML SUSPENSION ORAL Rx AB - ATOVAQUONEGLENMARK SPECLTANDA 2096852018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG/5ML SUSPENSION ORAL Rx AB - ATOVAQUONEHETERO LABS LTD IIIANDA 2106922018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG/5ML SUSPENSION ORAL Rx AB - ATOVAQUONELUPINANDA 2091052018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG/5ML SUSPENSION ORAL Discontinued — - ATOVAQUONEAPOTEXANDA 2097502017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG/5ML SUSPENSION ORAL Discontinued — - ATOVAQUONECHARTWELL RXANDA 2078332017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG/5ML SUSPENSION ORAL Rx AB - ATOVAQUONEAMNEAL PHARMSANDA 2029602014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG/5ML SUSPENSION ORAL Rx AB
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
34 yr 3 mo ago
Most recent approval
4 yr 11 mo ago
Approvals span 1992–2021 across 11 FDA applications.
Brand (NDA) 218%
Generic (ANDA) 982%
Atovaquone: 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.
