First Afinitor Generic Launched

December 10, 2019 – Par Pharmaceuticals has launched the first generic for Novartis's Afinitor® (everolimus) tablets. Everolimus is indicated to treat certain patients who have breast cancer, neuroendocrine tumors, renal cell carcinoma (RCC), or tuberous sclerosis complex (TSC).

An mTOR inhibitor, everolimus blocks an enzyme known as the mammalian target of rapamycin. Blocking the enzyme reduces the blood supply to cancer cells and prevents them from multiplying. Recommended dosing is based on the condition being treated.

Afinitor first received FDA approval in 2009 to treat RCC before receiving approval for additional indications. It is available in 2.5mg, 5mg, 7.5mg, and 10mg dosage strengths. Currently, there are no generics available for the 10mg strength, although that is expected to change in 2020. Par Pharmaceuticals' generic has a wholesale acquisition cost (WAC) of $12,565.37 per 28-count of 7.5mg tablets, compared to $15,706.71 for the brand.