Orange Book product · Brand (NDA)
VIJOICE
ALPELISIB
At a glance
Apr 24, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 24, 2024
2 yr 2 mo ago
Today
Patent 8476268 expires
Listed drug substance patent expiration.
Sep 10, 2029
in 3 yr 3 mo
Patent 8227462 expires
Listed drug substance patent expiration.
Apr 29, 2033
in 7 yr
Patent 11433059 expires
Listed method-of-use patent (U-4359) expiration.
Feb 17, 2037
in 10 yr 10 mo
Patent 12427141 expires
Listed method-of-use patent (U-4288) expiration.
Feb 17, 2037
in 10 yr 10 mo
Pharmaceutical detail
Active ingredient
ALPELISIB
Strength
50MG/PACKET
Dosage form
GRANULE
Route
ORAL
TE code
Not listed
Application
NDA 218466
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.
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8476268 | Sep 10, 2029 | in 3 yr 3 mo | SubstanceProduct |
| 8227462 | Apr 29, 2033 | in 7 yr | SubstanceProduct |
| 11433059 | Feb 17, 2037 | in 10 yr 10 mo | U-4359 |
| 12427141 | Feb 17, 2037 | in 10 yr 10 mo | U-4288 |
