Orange Book product · Brand (NDA)
DELSTRIGO
DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
At a glance
Aug 30, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
5
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
Patent 10603282 expires
Listed drug product patent expiration.
Nov 29, 2036
in 10 yr 7 mo
Patent 10842751 expires
Listed drug product patent expiration.
Nov 29, 2036
in 10 yr 7 mo
Pharmaceutical detail
Active ingredient
DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Strength
100MG;300MG;300MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 210807
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 (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8486975 | Aug 30, 2032 | in 6 yr 3 mo | SubstanceProductU-2629 |
| 8486975 | Aug 30, 2032 | in 6 yr 3 mo | SubstanceProductU-2395 |
| 8486975 | Aug 30, 2032 | in 6 yr 3 mo | SubstanceProductU-3307 |
| 10603282 | Nov 29, 2036 | in 10 yr 7 mo | Product |
| 10842751 | Nov 29, 2036 | in 10 yr 7 mo | Product |
