Orange Book product · Brand (NDA)
PIQRAY
ALPELISIB
At a glance
May 24, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 24, 2019
7 yr 2 mo ago
Today
Exclusivity ends · I-937
New indication exclusivity (3 years)
Jan 18, 2027
in 7 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
Pharmaceutical detail
Active ingredient
ALPELISIB
Strength
50MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 212526
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)
- I-937New indication exclusivity (3 years)
Jan 18, 2027
in 7 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8476268 | Sep 10, 2029 | in 3 yr 3 mo | SubstanceProduct |
| 8227462 | Apr 29, 2033 | in 7 yr | SubstanceProductU-3809 |
