FDA Orange Book
Is there a generic for Triumeq?
Triumeq contains abacavir, dolutegravir and lamivudine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Triumeq (abacavir, dolutegravir and lamivudine). The Orange Book shows its last listed patent expires June 8, 2030 and its last listed exclusivity ends December 15, 2026.
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Triumeq products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 600MG BASE;EQ 50MG BASE;300MG | Marketed (Rx) | None | 0 | None |
NDA 205551, held by VIIV HEALTHCARE CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Triumeq patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8129385 | October 5, 2027 | Drug substance, Drug product | None | 205551 |
| 8129385*PED | April 5, 2028 | Method of use | None | 205551 |
| 9242986 | December 8, 2029 | Drug substance, Drug product | None | 205551 |
| 9242986*PED | June 8, 2030 | Method of use | None | 205551 |
Triumeq exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-294 | Miscellaneous | June 15, 2026 | 205551 |
| PED | Pediatric exclusivity | December 15, 2026 | 205551 |
Triumeq NDC codes
Questions
Is there a generic for Triumeq?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Triumeq (abacavir, dolutegravir and lamivudine). The Orange Book shows its last listed patent expires June 8, 2030 and its last listed exclusivity ends December 15, 2026.
What is the generic name for Triumeq?
The active ingredient in Triumeq is abacavir, dolutegravir and lamivudine, per the FDA Orange Book.
When does the Triumeq patent expire?
The last patent listed for Triumeq in the Orange Book expires June 8, 2030. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on Triumeq and Abacavir, Dolutegravir and Lamivudine
- What is Triumeq used for?FDA label uses
- Is Triumeq a controlled substance?Federal schedule
- Generic for Triumeq PdFDA Orange Book
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- Triumeq Medicare Part D coverageBy plan and state
- NDC 49702-231Triumeq NDC record