FDA Orange Book · active-ingredient family
Abacavir sulfate; dolutegravir sodium; lamivudine
Abacavir sulfate; dolutegravir sodium; lamivudine is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:TRIUMEQ PD · NDA 215413
2
Brand (NDA)
0
Generics (ANDA)
4
Listed patents
4
Exclusivity periods
Brand (NDA) products · tablet, tablet, for suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRIUMEQ PDRLD | VIIV HLTHCARE | NDA 215413 | — | Mar 30, 2022 | |
| TRIUMEQRLD | VIIV HLTHCARE | NDA 205551 | — | Aug 22, 2014 |
Marketing exclusivity (4)
- NPPNew patient population exclusivity (3 years)
Jun 15, 2026
4 d ago
- PEDPediatric exclusivity (adds 6 months)
Dec 15, 2026
in 6 mo
- M-294New use / labeling-change exclusivity (3 years)
Jun 15, 2026
4 d ago
- PEDPediatric exclusivity (adds 6 months)
Dec 15, 2026
in 6 mo
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 |
Abacavir sulfate; dolutegravir sodium; lamivudine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
