FDA Orange Book
Is there a generic for Tivicay?
Tivicay contains dolutegravir. 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 Tivicay (dolutegravir). The Orange Book shows its last listed patent expires June 8, 2030.
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Tivicay products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 10MG BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 25MG BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 50MG BASE | Marketed (Rx) | None | 0 | None |
NDA 204790, 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.
Tivicay patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8129385 | October 5, 2027 | Drug substance, Drug product | None | 204790 |
| 8129385*PED | April 5, 2028 | Method of use | None | 204790 |
| 9242986 | December 8, 2029 | Drug substance, Drug product | None | 204790 |
| 9242986*PED | June 8, 2030 | Method of use | None | 204790 |
Tivicay NDC codes
Questions
Is there a generic for Tivicay?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tivicay (dolutegravir). The Orange Book shows its last listed patent expires June 8, 2030.
What is the generic name for Tivicay?
The active ingredient in Tivicay is dolutegravir, per the FDA Orange Book.
When does the Tivicay patent expire?
The last patent listed for Tivicay 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 Tivicay and Dolutegravir
- What is Tivicay used for?FDA label uses
- Is Tivicay a controlled substance?Federal schedule
- Generic for Tivicay PDFDA Orange Book
- Human Immunodeficiency Virus Integrase Strand Transfer Inhibitors listFDA drug class
- Tivicay Medicare Part D coverageBy plan and state
- NDC 49702-226Tivicay NDC record
- NDC 49702-227Tivicay NDC record
- NDC 49702-228Tivicay NDC record