Orange Book product · Brand (NDA)
TIVICAY
DOLUTEGRAVIR SODIUM
At a glance
Jun 09, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 09, 2016
10 yr 2 mo ago
Today
Patent 8129385 expires
Listed drug substance patent expiration.
Oct 05, 2027
in 1 yr 4 mo
Patent 8129385*PED expires
Listed listed patent expiration.
Apr 05, 2028
in 1 yr 10 mo
Patent 9242986 expires
Listed drug substance patent expiration.
Dec 08, 2029
in 3 yr 6 mo
Patent 9242986*PED expires
Listed listed patent expiration.
Jun 08, 2030
in 4 yr
Pharmaceutical detail
Active ingredient
DOLUTEGRAVIR SODIUM
Strength
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 204790
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8129385 | Oct 05, 2027 | in 1 yr 4 mo | SubstanceProduct |
| 8129385*PED | Apr 05, 2028 | in 1 yr 10 mo | |
| 9242986 | Dec 08, 2029 | in 3 yr 6 mo | SubstanceProduct |
| 9242986*PED | Jun 08, 2030 | in 4 yr |
