FDA Orange Book · active-ingredient family
Alpelisib
Alpelisib is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:VIJOICE · NDA 218466
3
Brand (NDA)
0
Generics (ANDA)
4
Listed patents
6
Exclusivity periods
Brand (NDA) products · granule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VIJOICERLD | NOVARTIS | NDA 218466 | — | Apr 24, 2024 | |
| VIJOICERLD×3 | NOVARTIS | NDA 215039 | — | Apr 05, 2022 | |
| PIQRAYRLD×3 | NOVARTIS | NDA 212526 | — | May 24, 2019 |
Marketing exclusivity (6)
- I-937New indication exclusivity (3 years)
Jan 18, 2027
in 7 mo
- I-937New indication exclusivity (3 years)
Jan 18, 2027
in 7 mo
- I-937New indication exclusivity (3 years)
Jan 18, 2027
in 7 mo
- ODE-396Orphan-drug exclusivity (7 years)
Apr 05, 2029
in 2 yr 10 mo
- ODE-396Orphan-drug exclusivity (7 years)
Apr 05, 2029
in 2 yr 10 mo
- 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 |
| 12427141 | Feb 17, 2037 | in 10 yr 10 mo | U-4288 |
| 11433059 | Feb 17, 2037 | in 10 yr 10 mo | U-4359 |
Alpelisib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
