FDA Orange Book
Is there a generic for Yeztugo?
Yeztugo 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 Yeztugo (lenacapavir). The Orange Book shows its last listed patent expires November 25, 2040 and its last listed exclusivity ends June 18, 2028.
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Yeztugo 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 220018, 220020, 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.
Yeztugo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9951043 | February 28, 2034 | Drug substance, Drug product | U-4190 | 220018 |
| 10071985 | August 17, 2037 | Drug substance, Drug product | None | 220018 |
| 11267799 | August 16, 2038 | Drug substance | None | 220018 |
| 12594267 | July 15, 2039 | Drug product | None | 220018 |
| 11807625 | November 25, 2040 | Method of use | U-4190 | 220018 |
Yeztugo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | December 22, 2027 | 220018 |
| NP | New product | June 18, 2028 | 220018 |
Yeztugo NDC codes
Questions
Is there a generic for Yeztugo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Yeztugo (lenacapavir). The Orange Book shows its last listed patent expires November 25, 2040 and its last listed exclusivity ends June 18, 2028.
What is the generic name for Yeztugo?
The active ingredient in Yeztugo is lenacapavir, per the FDA Orange Book.
When does the Yeztugo patent expire?
The last patent listed for Yeztugo in the Orange Book expires November 25, 2040. 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.