Drug

Who makes lapatinib?

4 companies list lapatinib as a human prescription drug, including under the names TYKERB. Forms: tablet; tablet, film coated. 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 lapatinib

CompanyFormsApplicationNDCsRegistered sites
Novartis Pharmaceuticals CorporationSwitzerlandtabletNDANDA022059120
Lupin LimitedIndiatabletANDAANDA203007114
Teva Pharmaceutical Industries Ltd.Canadatablet, film coatedANDAANDA21796816
AvKAREtablet, film coatedANDAANDA21796810

Bulk ingredient listings

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Common questions

Who makes lapatinib?
4 companies list lapatinib as a human prescription drug in the openFDA NDC Directory, led by Novartis Pharmaceuticals Corporation, Lupin Limited, Teva Pharmaceutical Industries Ltd., AvKARE. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic TYKERB?
3 companies list lapatinib under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
Who supplies lapatinib active ingredient?
1 company lists lapatinib as a bulk ingredient, including ThermoFisher Scientific Cork.