FDA Orange Book · active-ingredient family
Ritonavir
Ritonavir is approved as 5 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NORVIR · NDA 209512
5
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, powder, solution, tablet
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RITONAVIR | QUAGEN | ANDA 205024 | — | Feb 16, 2024 | |
| RITONAVIR | CIPLA | ANDA 203759 | AB | May 10, 2022 | |
| RITONAVIR | HIKMA | ANDA 205801 | — | Dec 03, 2020 | |
| RITONAVIR | AMNEAL | ANDA 208890 | — | Sep 17, 2018 | |
| RITONAVIR | AUROBINDO PHARMA LTD | ANDA 206614 | AB | Sep 17, 2018 | |
| RITONAVIR | HETERO LABS LTD III | ANDA 204587 | AB | Sep 17, 2018 | |
| RITONAVIR | CIPLA | ANDA 202573 | AB | Jan 15, 2015 |
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.
Ritonavir — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
