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The generic ingredient in EDURANT is rilpivirine hydrochloride. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rilpivirine hydrochloride profile page.
Generic Entry Opportunity Date for 202022
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 202022
Profile for product number 001
|Active Rx/OTC/Discontinued:||RX||Dosage:||TABLET;ORAL||Strength||EQ 25MG BASE|
|Approval Date:||May 20, 2011||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Feb 1, 2021|
|Regulatory Exclusivity Use:||INFORMATION ADDED TO SECTION 8.1 OF THE LABELING REGARDING PREGNANT PATIENTS WHO ARE ALREADY ON A STABLE RILPIVIRINE REGIMEN PRIOR TO PREGNANCY AND WHO ARE VIROLOGICALLY SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES/ML)|
|Regulatory Exclusivity Expiration:||Aug 26, 2018|
|Regulatory Exclusivity Use:||NEW PATIENT POPULATION|
|Patent:||➤ Sign Up||Patent Expiration:||Feb 26, 2021||Product Flag?||Y||Substance Flag?||Y||Delist Request?|
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