Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats human immunodeficiency virus (HIV-1) infection. Sold as Isentress, Isentress Hd. Every FDA application for this active ingredient: 3 branded and 2 generic.
As of Nov 15, 2026, FDA lists 5 applications for Raltegravir Potassium (sold as Isentress, Isentress Hd), first approved Oct 12, 2007, with 23 new uses approved and 0 published complete response letters.
First approved: Oct 12, 2007
Applications: 5
New uses approved: 23
Complete response letters: 0
Medicare spending, 2025: $121M
First approved in the EU: Dec 19, 2007
First approved in Japan: Jun 24, 2008
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 8 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Isentress, new approvalA drug with a new dosage and in an additional dosage form indicated for the treatment of HIV infection. · MSD K.K. · May 14, 2018
Isentress, new ingredientA drug containing a new active ingredient indicated for the treatment of HIV infection. · Banyu Pharmaceutical Co., Ltd. · Jun 24, 2008 · Review report
Clinical Trials
10 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
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
Lupin