Teva Pharmaceutical Industries has launched the generic equivalent to Novartis' Gleevec (imatinib mesylate) tablets,100 mg and 400 mg, in the US for multiple indications including leukemia. Gleevec, marketed as Glivec in Europe, had 2015 global sales of nearly $4.7 billion. The drug had annual sales of approximately $2.42 billion in the US, according to IMS data as of May 2016 and as reported by Teva.

Imatinib mesylate has multiple indications in the US, including newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase; patients with Ph+ CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy; and adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia.

The drug is also indicated in the US for adult patients with myelodysplastic/myeloproliferative diseases associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements; adult patients with aggressive systemic mastocytosis without the D816V c-Kit mutation or with c-Kit mutational status unknown; and adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion), as well as for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown.

In addition, it is indicated in the US for adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans; and adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive gastrointestinal stromal tumors.

Source: Teva Pharmaceuticals