Orange Book product · Brand (NDA)
EDURANT PED
RILPIVIRINE HYDROCHLORIDE
At a glance
Mar 15, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 15, 2024
2 yr 4 mo ago
Today
Exclusivity ends · NP
New product 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
Patent 11065198 expires
Listed drug product patent expiration.
Oct 23, 2037
in 11 yr 6 mo
Pharmaceutical detail
Active ingredient
RILPIVIRINE HYDROCHLORIDE
Strength
EQ 2.5MG BASE
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 219016
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)
- NPNew product exclusivity (3 years)
Mar 15, 2027
in 9 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 15, 2027
in 1 yr 3 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11065198 | Oct 23, 2037 | in 11 yr 6 mo | Product |
