FDA Orange Book · active-ingredient family
Lopinavir; ritonavir
Lopinavir; ritonavir is approved as 3 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:KALETRA · NDA 021906
3
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KALETRARLD×2 | ABBVIE | NDA 021906 | AB | Nov 09, 2007 | |
| KALETRARLD | ABBVIE | NDA 021251 | — | Sep 15, 2000 | |
| KALETRA | ABBVIE | NDA 021226 | — | Sep 15, 2000 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOPINAVIR AND RITONAVIR×2 | MICRO LABS | ANDA 214696 | AB | Dec 11, 2025 | |
| LOPINAVIR AND RITONAVIR×2 | MACLEODS PHARMS LTD | ANDA 204739 | AB | Jul 25, 2024 | |
| LOPINAVIR AND RITONAVIR×2 | MYLAN LABS LTD | ANDA 079074 | AB | Feb 07, 2024 | |
| LOPINAVIR AND RITONAVIR×2 | LAURUS | ANDA 213857 | AB | Mar 21, 2022 | |
| LOPINAVIR AND RITONAVIR×2 | HETERO LABS LTD III | ANDA 091677 | AB | Jun 04, 2021 | |
| LOPINAVIR AND RITONAVIR | LANNETT CO INC | ANDA 207407 | — | Dec 27, 2016 |
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.
Lopinavir; ritonavir — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
