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Treats HIV-1 infection. Sold as Kaletra, Lopinavir And Ritonavir. Every FDA application for this active ingredient: 4 branded and 10 generic.
As of Nov 15, 2026, FDA lists 14 applications for Lopinavir; Ritonavir (sold as Kaletra, Lopinavir And Ritonavir), first approved Sep 15, 2000, with 24 new uses approved and 0 published complete response letters.
First approved: Sep 15, 2000
Applications: 14
New uses approved: 24
Complete response letters: 0
Medicare spending, 2025: $3.0M
First approved in the EU: Mar 19, 2001
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Lopinavir-Ritonavir
Part D
$2.7M
-18%
516
Kaletra
Part D
$292K
-1%
44
Approvals in the EU (EMA)
First approved in the EU 6 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA