2 companies list alpelisib as a human prescription drug in the openFDA NDC Directory, led by Novartis Pharmaceuticals Corporation, Novartis Pharma Stein AG. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.

Who supplies alpelisib active ingredient?

2 companies list alpelisib as a bulk ingredient, including Novartis Pharmaceuticals Corporation, SciAnda (Changshu) Pharmaceuticals, Ltd..

Drug

Who makes alpelisib?

2 companies list alpelisib as a human prescription drug, including under the names PIQRAY, VIJOICE. Forms: granule; kit; tablet. Routes: oral.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing alpelisib

Company	Forms	Application	NDCs	Registered sites
Novartis Pharmaceuticals CorporationSwitzerland	granule; kit; tablet	NDANDA212526, NDA215039, NDA218466	7	20
Novartis Pharma Stein AG	tablet	DRUG FOR FURTHER PROCESSING	6	0

Bulk ingredient listings

Novartis Pharmaceuticals CorporationSwitzerland · 1 NDC
SciAnda (Changshu) Pharmaceuticals, Ltd.China · 1 NDC

Orange Book patents

4 unexpired patents list alpelisib as the active ingredient, expiring between Sept 2029 and Feb 2037. Application holder: NOVARTIS PHARMACEUTICALS CORP.

Enquiry

Common questions

Who makes alpelisib?: 2 companies list alpelisib as a human prescription drug in the openFDA NDC Directory, led by Novartis Pharmaceuticals Corporation, Novartis Pharma Stein AG. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Who supplies alpelisib active ingredient?: 2 companies list alpelisib as a bulk ingredient, including Novartis Pharmaceuticals Corporation, SciAnda (Changshu) Pharmaceuticals, Ltd..