Orange Book product · Brand (NDA)
YEZTUGO
LENACAPAVIR SODIUM
At a glance
Jun 18, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 18, 2025
1 yr ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Dec 22, 2027
in 1 yr 6 mo
Exclusivity ends · NP
New product exclusivity (3 years)
Jun 18, 2028
in 2 yr
Patent 9951043 expires
Listed drug substance patent expiration.
Feb 28, 2034
in 7 yr 10 mo
Patent 10071985 expires
Listed drug substance patent expiration.
Aug 17, 2037
in 11 yr 4 mo
Patent 11267799 expires
Listed drug substance patent expiration.
Aug 16, 2038
in 12 yr 4 mo
Pharmaceutical detail
Active ingredient
LENACAPAVIR SODIUM
Strength
EQ 300MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 220020
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- 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 (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9951043 | Feb 28, 2034 | in 7 yr 10 mo | SubstanceProductU-4190 |
| 10071985 | Aug 17, 2037 | in 11 yr 4 mo | SubstanceProduct |
| 11267799 | Aug 16, 2038 | in 12 yr 4 mo | Substance |
