FDA Orange Book
Is there a generic for Juluca?
Juluca contains dolutegravir and rilpivirine. 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 Juluca (dolutegravir and rilpivirine). The Orange Book shows its last listed patent expires September 5, 2038.
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Juluca products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 50MG BASE;EQ 25MG BASE | Marketed (Rx) | None | 0 | None |
NDA 210192, 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.
Juluca patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8129385 | October 5, 2027 | Drug substance, Drug product | None | 210192 |
| 8129385*PED | April 5, 2028 | Method of use | None | 210192 |
| 9242986 | December 8, 2029 | Drug substance, Drug product | None | 210192 |
| 9242986*PED | June 8, 2030 | Method of use | None | 210192 |
| 10426780 | January 24, 2031 | Drug substance, Drug product | U-257 | 210192 |
| 12011506 | September 5, 2038 | Drug product | None | 210192 |
Juluca NDC codes
Questions
Is there a generic for Juluca?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Juluca (dolutegravir and rilpivirine). The Orange Book shows its last listed patent expires September 5, 2038.
What is the generic name for Juluca?
The active ingredient in Juluca is dolutegravir and rilpivirine, per the FDA Orange Book.
When does the Juluca patent expire?
The last patent listed for Juluca in the Orange Book expires September 5, 2038. 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 Juluca and Dolutegravir and Rilpivirine
- What is Juluca used for?FDA label uses
- Is Juluca a controlled substance?Federal schedule
- Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitors listFDA drug class
- Human Immunodeficiency Virus Integrase Strand Transfer Inhibitors listFDA drug class
- Juluca Medicare Part D coverageBy plan and state
- NDC 49702-242Juluca NDC record