FDA Orange Book
Is there a generic for Dovato?
Dovato contains 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 Dovato (dolutegravir and lamivudine). The Orange Book shows its last listed patent expires January 24, 2031 and its last listed exclusivity ends April 5, 2027.
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Dovato products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 50MG BASE;300MG | Marketed (Rx) | None | 0 | None |
NDA 211994, 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.
Dovato patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8129385 | October 5, 2027 | Drug substance, Drug product | None | 211994 |
| 8129385*PED | April 5, 2028 | Method of use | None | 211994 |
| 9242986 | December 8, 2029 | Drug substance, Drug product | None | 211994 |
| 9242986*PED | June 8, 2030 | Method of use | None | 211994 |
| 11234985 | January 24, 2031 | Drug product | U-257 | 211994 |
Dovato exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | April 5, 2027 | 211994 |
Dovato NDC codes
Questions
Is there a generic for Dovato?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Dovato (dolutegravir and lamivudine). The Orange Book shows its last listed patent expires January 24, 2031 and its last listed exclusivity ends April 5, 2027.
What is the generic name for Dovato?
The active ingredient in Dovato is dolutegravir and lamivudine, per the FDA Orange Book.
When does the Dovato patent expire?
The last patent listed for Dovato in the Orange Book expires January 24, 2031. 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.
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