FDA Orange Book
Is there a generic for Vijoice?
Vijoice contains alpelisib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vijoice (alpelisib). The Orange Book shows its last listed patent expires February 17, 2037 and its last listed exclusivity ends April 5, 2029.
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Vijoice products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| granule, oral | 50MG/PACKET | Marketed (Rx) | None | 0 | None |
| tablet, oral | 125MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 200MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 50MG | Marketed (Rx) | None | 0 | None |
NDA 218466, 215039, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vijoice patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8476268 | September 10, 2029 | Drug substance, Drug product | None | 218466 |
| 8227462 | April 29, 2033 | Drug substance, Drug product | None | 218466 |
| 12427141 | February 17, 2037 | Method of use | U-4288 | 218466 |
| 11433059 | February 17, 2037 | Method of use | U-4359 | 218466 |
Vijoice exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-396 | Orphan drug exclusivity | April 5, 2029 | 215039 |
Vijoice NDC codes
Questions
Is there a generic for Vijoice?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vijoice (alpelisib). The Orange Book shows its last listed patent expires February 17, 2037 and its last listed exclusivity ends April 5, 2029.
What is the generic name for Vijoice?
The active ingredient in Vijoice is alpelisib, per the FDA Orange Book.
When does the Vijoice patent expire?
The last patent listed for Vijoice in the Orange Book expires February 17, 2037. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.