Orange Book product · Brand (NDA)
VIJOICE
ALPELISIB
At a glance
Apr 05, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 05, 2022
4 yr 3 mo ago
Today
Exclusivity ends · ODE-396
Orphan-drug exclusivity (7 years)
Apr 05, 2029
in 2 yr 10 mo
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
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 215039
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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)
- ODE-396Orphan-drug exclusivity (7 years)
Apr 05, 2029
in 2 yr 10 mo
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 |
