NDAORALTABLET, CHEWABLEPriority Review
Approved
Dec 2011
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Mechanism of Action
HIV-1 antiviral drug [see ] .
Indications (6)
combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients ()combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg ()combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg ()combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patientscombination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kgcombination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg
Clinical Trials (5)
Neuropsyquiatric Evolution After Introduction of Raltegravir QD in Substitution of Dolutegravir: NEAR QD Study
Started May 2019
50 enrolled
HIV Infections
Raltegravir One Thousand Two Hundred vs Darunavir-cb in Immnunosupressed Patients: ROTDIP Study
Started Apr 2019
75 enrolled
HIV Infections
Safety, Tolerability, and Pharmacokinetics of Raltegravir (MK-0518) in Healthy Japanese Male Participants (MK-0518-851)
Started Sep 2018
12 enrolled
Human Immunodeficiency Virus (HIV) Infection
Pharmacokinetics Distribution of Raltegravir by PET/MR
Started Apr 2018
10 enrolled
HIV-1-infection
Effect on Liver Fat and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Raltegravir
Started Jan 2018
45 enrolled
HIV SeropositivityMetabolic SyndromeFatty Liver
Loss of Exclusivity
LOE Date
Jun 2, 2030
51 months away
Patent Expiry
Jun 2, 2030
Patent Records (3)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 7754731 | Mar 11, 2029 | SubstanceProduct | U-257 |
| 7754731*PED | Sep 11, 2029 | — | |
| 8771733 | Jun 2, 2030 | SubstanceProduct | U-257 |