FDA Orange Book
Is there a generic for Bixlenvo Sunlenca Starter Pack (copackaged)?
Bixlenvo Sunlenca Starter Pack (copackaged) contains bictegravir sodium lenacapavir 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 Sunlenca Starter Pack (copackaged) (bictegravir sodium lenacapavir 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 Sunlenca Starter Pack (copackaged) 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; EQ 300MG BASE | Marketed (Rx) | None | 0 | None |
NDA 221443, 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 Sunlenca Starter Pack (copackaged) patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9732092 | December 19, 2033 | Drug substance, Drug product | None | 221443 |
| 9216996 | December 19, 2033 | Drug substance, Drug product | None | 221443 |
| 9951043 | February 28, 2034 | Drug substance, Drug product | U-4602 | 221443 |
| 10385067 | June 19, 2035 | Method of use | U-4602 | 221443 |
| 9708342 | June 19, 2035 | Drug substance, Drug product | None | 221443 |
| 10654827 | August 17, 2037 | Method of use | U-4602 | 221443 |
| 10071985 | August 17, 2037 | Drug substance, Drug product | None | 221443 |
| 11267799 | August 16, 2038 | Drug substance | None | 221443 |
Bixlenvo Sunlenca Starter Pack (copackaged) exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | December 22, 2027 | 221443 |
| NP | New product | August 27, 2029 | 221443 |
Questions
Is there a generic for Bixlenvo Sunlenca Starter Pack (copackaged)?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Bixlenvo Sunlenca Starter Pack (copackaged) (bictegravir sodium lenacapavir 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 Sunlenca Starter Pack (copackaged)?
The active ingredient in Bixlenvo Sunlenca Starter Pack (copackaged) is bictegravir sodium lenacapavir and lenacapavir, per the FDA Orange Book.
When does the Bixlenvo Sunlenca Starter Pack (copackaged) patent expire?
The last patent listed for Bixlenvo Sunlenca Starter Pack (copackaged) 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.