FDA Orange Book
Is there a generic for Tivicay PD?
Tivicay PD 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 PD (dolutegravir). The Orange Book shows its last listed patent expires June 8, 2030 and its last listed exclusivity ends February 25, 2030.
Run it in Rivvi
Map Tivicay PD and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Tivicay PD products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, for suspension, oral | EQ 5MG BASE | Marketed (Rx) | None | 0 | None |
NDA 213983, 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 PD patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8129385 | October 5, 2027 | Drug substance, Drug product | None | 213983 |
| 8129385*PED | April 5, 2028 | Method of use | None | 213983 |
| 9242986 | December 8, 2029 | Drug substance, Drug product | None | 213983 |
| 9242986*PED | June 8, 2030 | Method of use | None | 213983 |
Tivicay PD exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | August 25, 2029 | 213983 |
| PED | Pediatric exclusivity | February 25, 2030 | 213983 |
Tivicay PD NDC codes
Questions
Is there a generic for Tivicay PD?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tivicay PD (dolutegravir). The Orange Book shows its last listed patent expires June 8, 2030 and its last listed exclusivity ends February 25, 2030.
What is the generic name for Tivicay PD?
The active ingredient in Tivicay PD is dolutegravir, per the FDA Orange Book.
When does the Tivicay PD patent expire?
The last patent listed for Tivicay PD 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.