FDA Orange Book
Is there a generic for Bixlenvo?
Bixlenvo contains bictegravir and lenacapavir. 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 Bixlenvo (bictegravir and lenacapavir). The Orange Book shows its last listed patent expires August 16, 2038 and its last listed exclusivity ends August 27, 2029.
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Bixlenvo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 75MG BASE;EQ 50MG BASE | Marketed (Rx) | None | 0 | None |
NDA 221104, held by GILEAD SCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Bixlenvo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9732092 | December 19, 2033 | Drug substance, Drug product | None | 221104 |
| 9216996 | December 19, 2033 | Drug substance, Drug product | None | 221104 |
| 9951043 | February 28, 2034 | Drug substance, Drug product | U-4602 | 221104 |
| 10385067 | June 19, 2035 | Method of use | U-4602 | 221104 |
| 9708342 | June 19, 2035 | Drug substance, Drug product | None | 221104 |
| 10654827 | August 17, 2037 | Method of use | U-4602 | 221104 |
| 10071985 | August 17, 2037 | Drug substance, Drug product | None | 221104 |
| 11267799 | August 16, 2038 | Drug substance | None | 221104 |
Bixlenvo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | December 22, 2027 | 221104 |
| NP | New product | August 27, 2029 | 221104 |
Bixlenvo NDC codes
Questions
Is there a generic for Bixlenvo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Bixlenvo (bictegravir and lenacapavir). The Orange Book shows its last listed patent expires August 16, 2038 and its last listed exclusivity ends August 27, 2029.
What is the generic name for Bixlenvo?
The active ingredient in Bixlenvo is bictegravir and lenacapavir, per the FDA Orange Book.
When does the Bixlenvo patent expire?
The last patent listed for Bixlenvo in the Orange Book expires August 16, 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.