September 30, 2020

Lupin Pharmaceuticals has announced the launch of its generic version of Novartis’s Tykerb® (lapatinib) 250mg tablets. Lapatinib is indicated for the following FDA-approved uses:

  • In combination with capecitabine to treat advanced or metastatic breast cancer in patients whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy including an anthracycline, a taxane, and trastuzumab; or
  • In combination with letrozole to treat postmenopausal women who have hormone-receptor positive metastatic breast cancer that overexpresses the HER2 receptor and for whom hormonal therapy is indicated.

Tykerb first received FDA approval in 2007. Recommended dosing for Tykerb and its generic is based on the indication. A black box warning cautions that hepatotoxicity has been observed in clinical trials and postmarketing experience with lapatinib. Hepatotoxicity may be severe, and deaths have been reported, though the causality of the deaths is uncertain.

Lupin’s generic is available at a wholesale acquisition cost (WAC) of $48.11 per tablet, versus $55.69 for the brand name version.

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