Orange Book product · Brand (NDA)
SUNLENCA
LENACAPAVIR SODIUM
At a glance
Dec 22, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
6
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 12594267 expires
Listed drug product patent expiration.
Jul 15, 2039
in 13 yr 3 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 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 215973
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 (6)
| 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 |
| 12594267 | Jul 15, 2039 | in 13 yr 3 mo | Product |
| 11944611 | Aug 28, 2041 | in 15 yr 5 mo | U-3507 |
