abacavir / dolutegravir / Lamivudine Oral Tablet
- Brand(s)
- Triumeq
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Viiv Healthcare Company (2015-09-28)
- Oldest Current Product
- 2014-08-22
- License(s)
- NDA
- RxNORM
- ORAL TABLET\ABACAVIR:DOLUTEGRAVIR:LAMIVUDINE
- FDAOB
- ORAL\TABLET\ABACAVIR SULFATE: DOLUTEGRAVIR SODIUM: LAMIVUDINE
- SPL Active
- ORAL\TABLET, FILM COATED\ABACAVIR SULFATE: DOLUTEGRAVIR SODIUM: LAMIVUDINE
- SPL Moiety
- ORAL\TABLET, FILM COATED\ABACAVIR: DOLUTEGRAVIR: LAMIVUDINE
product(s) by strength(s)
abacavir 600 mg / dolutegravir 50 mg / lamivudine 300 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 497020231 | Triumeq | NDA | Viiv Healthcare Company | 2014-08-22 | ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE | ORAL | TABLET, FILM COATED | NDA205551 | 2997739a-aa91-42aa-a206-a70e2db7b84f |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA205551 | TRIUMEQ | VIIV HEALTHCARE CO | 2014-08-22 | p6294540, TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION., SUBSTANCE p8129385, SUBSTANCE p6417191, TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION., SUBSTANCE p5905082, SUBSTANCE | NEW CHEMICAL ENTITY [2018-08-12] | NDA205551_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA205551_001 | RX | ABACAVIR SULFATE (EQ 600MG BASE), LAMIVUDINE (300MG), DOLUTEGRAVIR SODIUM (EQ 50MG BASE) | ORAL | TABLET | True | 2014-08-22 | TRIUMEQ |
patent(s)
| # | id | expiration date | application(s) | in other drug docs |
|---|---|---|---|---|
| 1 | p5905082 (view patent) | 2016-05-18 | NDA205551, NDA020564, NDA020596, NDA020857, NDA021003, NDA021205, NDA021652 | abacavir / Lamivudine Oral Tablet abacavir / Lamivudine / Zidovudine Oral Tablet Lamivudine Oral Tablet Lamivudine / Zidovudine Oral Tablet Lamivudine Oral Solution |
| 2 | p6294540 (view patent) | 2018-05-14 | NDA205551, NDA020977, NDA020978, NDA021205, NDA021652 | abacavir / Lamivudine Oral Tablet abacavir / Lamivudine / Zidovudine Oral Tablet abacavir Oral Solution abacavir Oral Tablet |
| 3 | p6417191 (view patent) | 2016-03-28 | NDA205551, NDA021205, NDA021652 | abacavir / Lamivudine Oral Tablet abacavir / Lamivudine / Zidovudine Oral Tablet |
| 4 | p8129385 (view patent) | 2027-10-05 | NDA205551, NDA204790 | dolutegravir Oral Tablet |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 2997739a-aa91-42aa-a206-a70e2db7b84f (view SPL) | These highlights do not include all the information needed to use TRIUMEQ safely and effectively. See full prescribing information for TRIUMEQ.TRIUMEQ (abacavir, dolutegravir, and lamivudine) tablets for oral useInitial U.S. Approval: 2014 | prescription | Human Prescription | Viiv Healthcare Company | 2015-09-28 | 5 | 497020231 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII