Orange Book product · Brand (NDA)
EDURANT
RILPIVIRINE HYDROCHLORIDE
At a glance
May 20, 2011
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 20, 2011
15 yr 4 mo ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Mar 15, 2027
in 9 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Sep 15, 2027
in 1 yr 3 mo
Pharmaceutical detail
Active ingredient
RILPIVIRINE HYDROCHLORIDE
Strength
EQ 25MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 202022
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- NPPNew patient population exclusivity (3 years)
Mar 15, 2027
in 9 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 15, 2027
in 1 yr 3 mo
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
