Orange Book product · Brand (NDA)
SUNLENCA
LENACAPAVIR SODIUM
At a glance
Dec 22, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 2022
3 yr 7 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Dec 22, 2027
in 1 yr 6 mo
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 10654827 expires
Listed method-of-use patent (U-3507) 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
Patent 11944611 expires
Listed method-of-use patent (U-3507) expiration.
Aug 28, 2041
in 15 yr 5 mo
Pharmaceutical detail
Active ingredient
LENACAPAVIR SODIUM
Strength
EQ 300MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 215974
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 (1)
- NCENew chemical entity exclusivity (5 years)
Dec 22, 2027
in 1 yr 6 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9951043 | Feb 28, 2034 | in 7 yr 10 mo | SubstanceProductU-3507 |
| 10071985 | Aug 17, 2037 | in 11 yr 4 mo | SubstanceProduct |
| 10654827 | Aug 17, 2037 | in 11 yr 4 mo | U-3507 |
| 11267799 | Aug 16, 2038 | in 12 yr 4 mo | Substance |
| 11944611 | Aug 28, 2041 | in 15 yr 5 mo | U-3507 |
