FDA Orange Book · active-ingredient family
Lenacapavir sodium
Lenacapavir sodium is approved in 4 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:YEZTUGO · NDA 220018
4
Brand (NDA)
0
Generics (ANDA)
7
Listed patents
6
Exclusivity periods
Brand (NDA) products · solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| YEZTUGORLD | GILEAD SCIENCES INC | NDA 220018 | — | Jun 18, 2025 | |
| YEZTUGORLD | GILEAD SCIENCES INC | NDA 220020 | — | Jun 18, 2025 | |
| SUNLENCARLD | GILEAD SCIENCES INC | NDA 215973 | — | Dec 22, 2022 | |
| SUNLENCARLD | GILEAD SCIENCES INC | NDA 215974 | — | Dec 22, 2022 |
Marketing exclusivity (6)
- NCENew chemical entity exclusivity (5 years)
Dec 22, 2027
in 1 yr 6 mo
- NCENew chemical entity exclusivity (5 years)
Dec 22, 2027
in 1 yr 6 mo
- NPNew product exclusivity (3 years)
Jun 18, 2028
in 2 yr
- NCENew chemical entity exclusivity (5 years)
Dec 22, 2027
in 1 yr 6 mo
- NCENew chemical entity exclusivity (5 years)
Dec 22, 2027
in 1 yr 6 mo
- NPNew product exclusivity (3 years)
Jun 18, 2028
in 2 yr
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9951043 | Feb 28, 2034 | in 7 yr 10 mo | SubstanceProductU-3507 |
| 10654827 | Aug 17, 2037 | in 11 yr 4 mo | U-3507 |
| 10071985 | Aug 17, 2037 | in 11 yr 4 mo | SubstanceProduct |
| 11267799 | Aug 16, 2038 | in 12 yr 4 mo | Substance |
| 12594267 | Jul 15, 2039 | in 13 yr 3 mo | Product |
| 11807625 | Nov 25, 2040 | in 14 yr 8 mo | U-4190 |
| 11944611 | Aug 28, 2041 | in 15 yr 5 mo | U-3507 |
Lenacapavir sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
