FDA Orange Book · active-ingredient family
Atovaquone
Atovaquone is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MEPRON · NDA 020500
2
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ATOVAQUONE | PAI HOLDINGS | ANDA 214272 | AB | Oct 25, 2021 | |
| ATOVAQUONE | BIONPHARMA | ANDA 212918 | AB | Mar 30, 2021 | |
| ATOVAQUONE | ABHAI LLC | ANDA 210510 | AB | May 31, 2019 | |
| ATOVAQUONE | GLENMARK SPECLT | ANDA 209685 | AB | Nov 21, 2018 | |
| ATOVAQUONE | HETERO LABS LTD III | ANDA 210692 | AB | Oct 11, 2018 | |
| ATOVAQUONE | LUPIN | ANDA 209105 | — | Sep 11, 2018 | |
| ATOVAQUONE | APOTEX | ANDA 209750 | — | Oct 11, 2017 | |
| ATOVAQUONE | CHARTWELL RX | ANDA 207833 | AB | Apr 28, 2017 | |
| ATOVAQUONE | AMNEAL PHARMS | ANDA 202960 | AB | Mar 18, 2014 |
Listed patents
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.
Atovaquone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
