NDAORALTABLET, FOR SUSPENSIONPriority Review
Approved
Mar 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
1
Mechanism of Action
12.1 Mechanism of Action Rilpivirine is an antiviral drug [see ] . 12.2 Pharmacodynamics Effects on Electrocardiogram The effect of EDURANT at the recommended dose of 25 mg once daily on the QTcF interval was evaluated in a randomized, placebo and active (moxifloxacin 400 mg once daily) controlled…
Indications (17)
human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 2 years of ageolderweighing at least 14 kg with plasma HIV-1 RNA less thanequal to 100,000 copies/mL at the start of therapycombination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 2 years of ageweighing at least 14 kg with HIV-1 RNA less thanequal to 100,000 copies/mLcombination with VOCABRIA (cabotegravir)for short-term treatment of HIV-1 infection in adultsadolescents 12 yearsweighing at least 35 kgno knownsuspected resistance to either cabotegravirrilpivirinecombination with VOCABRIA (cabotegravir) for short-term treatment of HIV-1 infection in adultsfor usea component of CABENUVA (cabotegravir extended-release injectable suspension
Clinical Trials (1)
A Study on the Safety and Effectiveness of Rilpivirine Hydrochloride (Edurant) Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection
Started Jun 2013
0Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Loss of Exclusivity
LOE Date
Oct 23, 2037
141 months away
Patent Expiry
Oct 23, 2037
Exclusivity Expiry
Sep 15, 2027
Patent Records (1)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 11065198 | Oct 23, 2037 | Product | — |