FDA Orange Book
Is there a generic for Piqray?
Piqray 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 Piqray (alpelisib). The Orange Book shows its last listed patent expires April 29, 2033 and its last listed exclusivity ends January 18, 2027.
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Piqray products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 150MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 200MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 50MG | Marketed (Rx) | None | 0 | None |
NDA 212526, 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.
Piqray patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8476268 | September 10, 2029 | Drug substance, Drug product | None | 212526 |
| 8227462 | April 29, 2033 | Drug substance, Drug product | U-3809 | 212526 |
Piqray exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-937 | New indication | January 18, 2027 | 212526 |
Piqray NDC codes
Questions
Is there a generic for Piqray?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Piqray (alpelisib). The Orange Book shows its last listed patent expires April 29, 2033 and its last listed exclusivity ends January 18, 2027.
What is the generic name for Piqray?
The active ingredient in Piqray is alpelisib, per the FDA Orange Book.
When does the Piqray patent expire?
The last patent listed for Piqray in the Orange Book expires April 29, 2033. 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.