Orange Book product · Brand (NDA)
PIFELTRO
DORAVIRINE
At a glance
Aug 30, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 30, 2018
7 yr 11 mo ago
Today
Patent 8486975 expires
Listed drug substance patent expiration.
Aug 30, 2032
in 6 yr 3 mo
Patent 8486975 expires
Listed drug substance patent expiration.
Aug 30, 2032
in 6 yr 3 mo
Patent 8486975 expires
Listed drug substance patent expiration.
Aug 30, 2032
in 6 yr 3 mo
Pharmaceutical detail
Active ingredient
DORAVIRINE
Strength
100MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 210806
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.
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8486975 | Aug 30, 2032 | in 6 yr 3 mo | SubstanceProductU-2630 |
| 8486975 | Aug 30, 2032 | in 6 yr 3 mo | SubstanceProductU-2394 |
| 8486975 | Aug 30, 2032 | in 6 yr 3 mo | SubstanceProductU-3308 |
