Prescription medicine
Alpelisib Brand names: Vijoice, Piqray
Alpelisib (Vijoice) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the alpelisib FDA label on DailyMed (effective November 4, 2025, Novartis Pharmaceuticals Corporation); the NDA 212526 record on Drugs@FDA; every alpelisib label on DailyMed.
Highlights of the record
FDA label of November 4, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVIJOICE is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.
Forms and strengths
- 50 mg
- 125 mg
- 150 mg
- 200 mg
Tablet; kit; granule.
On the market
- Earliest approval on file
- May 24, 2019 Piqray, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 17, 2037 Vijoice tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 8,666 through July 30, 2026
What is alpelisib used for?
From the label: indications and usageVIJOICE is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). VIJOICE is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. […]
Source: FDA drug label (VIJOICE), Novartis Pharmaceuticals Corporation, effective November 4, 2025 (SPL set 638069a4-aee0-46c9-9e21-54ad449c163c), via openFDA; the full label on DailyMed
Is there a generic for alpelisib (Vijoice)?
No generic alpelisib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Vijoice tablets: the compound patent runs to April 29, 2033, and the last listed entry to February 17, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the alpelisib label say about other medicines?
The alpelisib label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Fulvestrant | warnings and precautions | Advise patients of potential risk to a fetus and to use effective contraception. ( 5.6 , 8.1 , 8.3 ) Refer to the Full Prescribing Information of fulvestrant for pregnancy and contraception information. |
| Loperamide | warnings and precautions | In clinical trials, 63% of patients who experienced diarrhea required antidiarrheal medications (e.g., loperamide) to manage symptoms. |
| Metformin | warnings and precautions | Consider premedication with metformin prior to the initiation of PIQRAY based on patient risk factors for hyperglycemia, gastrointestinal tolerability, and clinical situation. |
Source: FDA drug label (VIJOICE), Novartis Pharmaceuticals Corporation, effective November 4, 2025 (SPL set 638069a4-aee0-46c9-9e21-54ad449c163c), via openFDA; the full label on DailyMed
What do FAERS reports show for alpelisib?
The FDA Adverse Event Reporting System holds 8,666 reports that list alpelisib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,224 are coded as a death and 1,686 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2022 (1,783, against a median of 555 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Alpelisib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other