FDA Orange Book
Is there a generic for Sunlenca?
Sunlenca contains 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 Sunlenca (lenacapavir). The Orange Book shows its last listed patent expires August 28, 2041 and its last listed exclusivity ends August 27, 2029.
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Sunlenca products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 300MG BASE | Marketed (Rx) | None | 0 | None |
NDA 215973, 215974, 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.
Sunlenca patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9951043 | February 28, 2034 | Drug substance, Drug product | U-3507 | 215973 |
| 9951043 | February 28, 2034 | Drug substance, Drug product | U-4602 | 215974 |
| 10654827 | August 17, 2037 | Method of use | U-3507 | 215973 |
| 10071985 | August 17, 2037 | Drug substance, Drug product | None | 215973 |
| 10654827 | August 17, 2037 | Method of use | U-4602 | 215974 |
| 11267799 | August 16, 2038 | Drug substance | None | 215973 |
| 12594267 | July 15, 2039 | Drug product | None | 215973 |
| 11944611 | August 28, 2041 | Method of use | U-3507 | 215973 |
Sunlenca exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | December 22, 2027 | 215973 |
| I-999 | New indication | August 27, 2029 | 215974 |
Sunlenca NDC codes
Questions
Is there a generic for Sunlenca?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Sunlenca (lenacapavir). The Orange Book shows its last listed patent expires August 28, 2041 and its last listed exclusivity ends August 27, 2029.
What is the generic name for Sunlenca?
The active ingredient in Sunlenca is lenacapavir, per the FDA Orange Book.
When does the Sunlenca patent expire?
The last patent listed for Sunlenca in the Orange Book expires August 28, 2041. 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.